Clinical Research Associate Jobs in Pleasanton, CA

Summary and Scope: We are seeking a highly motivated and experienced Clinical Trial Manager (CTM) or Senior Clinical Trial Manager (Sr. CTM) to contribute to the operational execution of a global, pivotal clinical trial. The successful candidate will be a key member of the clinical operations team and will be responsible for overseeing various aspects of the trial from startup through closeout, ensuring adherence to timelines, budget, quality standards, and regulatory requirements. Guiding Principles: The below principles drive all that we do here at Tempest. We are looking for like-minded individuals who feel passionately about these same principles to join our team. Develop meaningful therapies for patients Value diversity in building teams Commit to growth and collaboration Work with integrity and rigor Embrace the energy that drives a successful biotech Responsibilities (not limited to the below and may evolve over time and change depending on business needs and individual expertise): Trial Management: Contribute to the planning, implementation, and execution of a global, pivotal clinical trial. Develop and manage study timelines, budget, and resources. Oversee the selection, contracting, and management of CROs, vendors, and investigative sites, and ensures that performance expectations are met. Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines). Ensure compliance with GCP, ICH guidelines, and all applicable regulations. Proactively identify and mitigate potential risks to trial execution. Site Management: Support site selection, qualification, initiation, and monitoring activities. Ensure timely enrollment and data collection at clinical trial sites. Address and resolve site-related issues effectively. Communication and Collaboration: Foster effective communication and collaboration within the study team and with external stakeholders. Provide regular updates on trial progress to senior management. Lead cross-functional and clinical operations team meetings. Contribute to the preparation of study reports, presentations, and publications. Vendor Management: Oversee the performance of CROs and other vendors involved in the trial. Ensure vendor compliance with contractual obligations and quality standards. Data Management: Collaborate with the data management team to ensure data integrity and timely database lock. Review and analyze clinical trial data to identify trends and potential issues. Regulatory Compliance: Maintain accurate and complete trial documentation. Contribute to the preparation of regulatory submissions (e.g., IND, CTA). Ensure compliance with all applicable regulations and guidelines. Education, Experience & Qualifications: Bachelor's degree in a life sciences discipline; advanced degree (e.g., MS, PhD) preferred. Experience: CTM - Minimum of 5-7 years of experience in clinical trial management, with at least 1 year in oncology and 2 years as a study manager. OR Sr. CTM - Minimum of 7-9 years of experience in clinical trial management, with at least 2 years in oncology and 4 years as a study manager. Strong understanding of clinical trial methodology, GCP, ICH guidelines, and relevant regulations. Experience with all phases of clinical trial execution, from startup to closeout. Excellent project management, organizational, and communication skills. Must be able to develop and present varied and unique ideas. Proven ability to work independently and as part of a team. Experience in liver cancer or other solid tumor indications is highly desirable. Ability to travel up to 15% of the time. About Tempest Therapeutics: Tempest Therapeutics is a clinical-stage biotechnology company developing small molecule therapeutics to treat cancer through mechanisms that directly kill tumor cells and activate tumor-specific immunity. The company's leadership comprises experienced oncology drug discovery and development professionals who share a common goal of advancing novel therapeutics that will bring meaningful benefit to patients. Tempest is headquartered in Brisbane, CA and is publicly traded on the NASDAQ under the ticker symbol TPST. More information about Tempest can be found on the company's website at ****************** Please note this is not a remote position. The right candidate will be onsite at our Brisbane, CA headquarters at least 3 days per week. Tempest offers a competitive salary and benefits package and prides itself on being an awesome place to work. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We anticipate the base salary for the Clinical Trial Manager/Senior Clinical Trial Manager position in our Brisbane, CA office to range from $130,000 to $190,000 and will depend on current market data and the candidate's qualifications for the role, including education and experience. The compensation described above is subject to change and could be higher or lower than the range described based on several factors. Qualified candidates should forward a resume and cover letter to: ********************* NO PHONE CALLS or AGENCIES, please.

Job title: Sr Clinical Trial Manager About Us About SiteOne SiteOne Therapeutics is a biopharmaceutical company developing treatments for hypersensitivity disorders of the nervous system such as pain, cough and epilepsy. Our values are scientific rigor, intensity, teamwork and commitment to our shared mission of developing transformative medicines for the benefit of patients. Our drug candidates are exquisitely selective modulators of ion channels, and are under investigation by both systemic and local routes of administration. An opportunity is currently available for a talented and motivated individuals to join our team. Hybrid and remote options are available. Key Responsibilities We are seeking an accomplished and results-driven Senior Clinical Trials Manager who will be responsible for: Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives. Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines. Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., central labs, study specific vendors, independent contractors) to execute clinical trials. Reviewing and contributing to the development of study-specific documentation including clinical trial protocols, informed consent forms, case report forms, and study guides/manuals. Reviewing monitoring reports and other study documentation as required. Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF). Lead study management team meetings and collaborate with other functional groups within the company (e.g., Clinical Research, Biometrics, Clinical Supply, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals. Following up on assigned team action items and identification, escalation, and resolution of issues as needed. Conduct in-person or remote site visits (e.g., training visits, site initiation visits, monitoring visits), as required. Qualifications BA/BS required with a minimum of 6 years of industry experience in clinical operations within the biopharmaceutical industry: Experience in managing Phase 1-3 clinical studies that relies on clinical outsourcing Leading internal and external teams, including CROs, vendors, and consultants Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team. Must display strong organizational, analytical and problem-solving skills at a project level and collaborate with colleagues to generate solutions Strong communication and influence skills and ability to create a clear sense of direction Ability to deal with time demands or unexpected events and escalate, when appropriate Knowledgeable of FDA, EMA, ICH and GCP regulations and guidelines Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities Ability to travel as required for the program (25%)

Job Title: Senior Clinical Trial Manager We are currently seeking an experienced and motivated Senior Clinical Trial Manager to join our client's team. In this pivotal role, you will oversee and manage clinical trial operations across multiple studies and programs, ensuring successful execution in alignment with timelines, budgets, and regulatory requirements. Key Responsibilities: Lead and manage Phase 1-3 clinical trials from initiation through to completion, ensuring high-quality deliverables. Oversee and coordinate multiple clinical studies, driving seamless execution and adherence to project milestones. Collaborate with cross-functional teams, vendors, and external stakeholders to ensure optimal study performance and compliance with GCP, ICH, and regulatory standards. Provide leadership and mentoring to clinical trial teams, fostering a culture of performance and professional growth. Manage study timelines, budgets, and resources to ensure studies are delivered on time and within scope, while maintaining high-quality standards. Key Requirements: Proven experience managing early phase clinical trials, with a strong understanding of clinical trial operations and regulatory guidelines. Experience managing global clinical trials Demonstrated expertise in program management and successfully overseeing multiple studies simultaneously. Ability to work onsite 2x per week in South San Francisco, CA. Strong leadership, organizational, and communication skills, with a proven ability to manage complex studies and lead cross-functional teams effectively. Apply for full company details and job description!

Research Associate/Senior Research Associate - Immunology & Murine Disease Modeling A dynamic and innovative biotech company is seeking a skilled Research Associate or Senior Research Associate to join its research and development team. This role offers an exciting opportunity to contribute to groundbreaking work in immunology and age-related diseases while growing as a researcher and leader. The position involves designing and executing critical experiments in a fast-paced and collaborative environment. Key Responsibilities Conduct in vivo animal studies, including models such as bleomycin-induced lung fibrosis and metabolic-related diseases like high-fat diet-induced diabetes. Perform animal research procedures, including monitoring, dosing, necropsy, and organ collection, to support target validation, mechanism of action studies, and immune analysis using ELISAs and flow cytometry. Assist in experimental design, execution, data analysis, and reporting. Qualifications & Skills B.S. in biology or a related field with 3-7 years of industry experience in rodent models of lung disease (preference for bleomycin-induced lung fibrosis, but experience with asthma/COPD models is also valuable). Strong background in animal handling with proficiency in various in vivo dosing techniques (i.v., intratracheal, i.p., s.c., i.n., p.o.), as well as organ and blood collection/dissection methods. Ability to support IACUC submissions, study design, execution, and data analysis with strong presentation skills. Experience in immunoassays such as ELISAs and flow cytometry is advantageous. Proficiency in software tools like Excel, Word, PowerPoint, and Prism. Strong organizational skills, teamwork mindset, and adaptability to a fast-paced biotech startup environment. Compensation & Benefits This position offers a competitive salary stock options, and a comprehensive benefits package, along with a monthly stipend for wellness activities. The company is committed to fostering career growth through professional development opportunities, including online courses, seminars, and conferences. The organization values diversity and welcomes applications from individuals of all backgrounds.

*** MUST BE LOCAL TO CA OR NY STATE - NO EXCEPTIONS *** Salary: $100K-$125K Company Summary: A global, specialty pharmaceutical group with an impressive track record is seeking a motivated Clinical Research Associate for a hybrid role at their San Francisco site. Their commercial supply of pharmaceutical products generated $83m in revenue in FY2023 (a 24% uptick from the year prior). Since their first clinical trials in 2006, they've had 3 approvals already on the market. Currently, they have 6 indications in Phases II and III, so they are looking for a driven, growth-oriented Clinical Research Associate to facilitate their in house studies. The CRA will be responsible for: Managing and investigating clinical trials and/or post-authorization safety studies Performing and coordinating different aspects of clinical monitoring and site management 20-25% travel (1x a month) An ideal candidate for this role MUST have… 2+ years of ONSITE monitoring experience at a sponsor or CRO (academia does NOT count) A Bachelor's degree in Biological Sciences, Nursing, Pharmacy or a related discipline A working knowledge of ICH GCP guidelines Benefits: Competitive salary with benefits High degree of commercial exposure early in your career Being a part of team whose work directly aims to improve the quality of people's lives Great work-life balance If you are interested in this Clinical Research Associate role, don't hesitate to reach out!

Research Associate (RA & SRA) South San Francisco, CA (Open to flex hours dependent on location) 6-Month Initial Contract (Strong Potential for Extension or FTE Conversion) This role focuses on biochemical and biophysical assay development, protein characterization, and data analysis in a drug discovery setting. The ideal candidate will have hands-on experience with techniques like SPR, TR-FRET, FP, and LC/MS for protein characterization, along with expertise in analyzing large datasets using Genedata Screener or Expressionist. Preferred qualifications include experience with cell-based assays, automation, molecular glue mechanisms, and coding for data analysis. Industry experience is preferred, though strong academic candidates may be considered for lower-level roles. Key Qualifications (Non-Negotiables): Biochemical & Biophysical Assays: Practical experience with SPR, TR-FRET, FP, BLI, ITC, nano DSF, MSD, etc. (Industry experience preferred; if strictly academic, expect a lower-level placement.) Protein Characterization: Proficiency in LC/MS-based protein characterization techniques. Data Analysis & Visualization: Understanding of dry lab workflows and experience with Genedata Screener and/or Expressionist for handling large datasets. Nice to Have: Cell-Based Assay Development: Hands-on experience with NanoBRET, CTG, AlphaLISA, or similar techniques. Drug Discovery Exposure: Familiarity with hit identification, validation, and screening platforms. Molecular Glues Knowledge: Any experience or baseline understanding of molecular glue mechanisms. Automation & Liquid Handling: Experience with SPT Dragonfly, Mosquito, Echo, Hamilton, etc. (Typically found in startups and smaller biotech companies.) Coding for Data Analysis: Experience with Python, R, or other scripting languages to support assay and screening workflows.

Senior Clinical Research Associate (Sr. CRA) As a Senior Clinical Research Associate (Sr. CRA), you will manage and monitor clinical studies across U.S. and international sites, ensuring compliance with FDA, ICH-GCP, and regulatory guidelines. This role requires strong organizational skills, attention to detail, and the ability to work independently while supporting multiple studies. Key Responsibilities: Provide case support and oversight of study activities. Develop and manage clinical documents, including informed consent forms and study guides. Monitor study sites, review case report forms, and ensure protocol adherence. Prepare study monitoring tools, reports, and regulatory documentation. Support IRB/IEC submissions and regulatory compliance. Track and resolve study queries, protocol deviations, and adverse events. Coach and mentor CRAs while ensuring adherence to study timelines. Participate in site audits and ensure proper investigational product accountability. Qualifications: BS/BA degree or equivalent experience. 5+ years in clinical research, with at least 3 years as a CRA in device or biotech trials. Cardiovascular device experience preferred. CRA certification (CCRA, CCRP) strongly preferred. Proficient in EDC, CTMS, Microsoft Office, and Smartsheet. Strong knowledge of FDA and international regulatory requirements. Excellent communication, critical thinking, and organizational skills. Ability to travel 30%-50%, including overnight and international travel. .

Why Nuvig Be a part of a potential game-changer for patients with autoimmune disease! Nuvig Therapeutics is developing novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are developed to be active for a broad spectrum of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies, such as immunodeficiency and increased cancer risk. In early 2024, our Development Candidate NVG-2089 advanced to a Ph 1b trial in patients. This is an opportunity to play a key role in the success of an early-stage organization working to advance innovative and transformational therapies to improve treatment options for patients. Join us in making a dramatic difference in patients' lives! Position Summary The in-house (Senior) Clinical Research Associate (CRA) is responsible for the coordination and oversight of activities involving the planning, initiation, and management of clinical trials. This role focuses on enrollment, data quality, and maintaining strong relationships with investigational site while ensuring adherence to protocols, SOPs, and regulatory guidelines such as ICH/GCP. The (Senior) CRA coordinates the activities performed by CROs and other vendors, and supports internal team members in the oversight and execution of the study, including timely escalation of issues that arise as appropriate. Acting as a cross-functional liaison, the (Senior) CRA ensures that the study is executed according to the established timelines and milestones while remaining within budget. This role is vital in fostering a positive and collaborative team environment. The (Senior) CRA will report to the VP, Development Operations. Responsibilities Support study team in adherence to timeline, study quality, budget for assigned studies and sites Support communication between the sponsor, CRO, site personnel and other study vendors Support execution of internal team meetings, development of meeting minutes, and timely distribution to cross-functional team members Support the maintenance of internal study logs and trackers (risk log, enrollment trackers, site activation, training logs, etc.) Lead the periodic reviews and maintenance of study level TMF and oversight of CRO management of TMF Assist with the management and oversight of clinical trial systems (UAT, system access management, system vendor oversight) Lead development and distribution of study newsletters Support internal site payment process (accessing reports from EDC, verification of site activity and confirmation of site payment) Support study level IP management activities including IP accountability and reconciliation process for assigned studies Support study level lab sample management activities Develop and manage study level storyboards Support Investigator Meeting planning activities and planning of other external meetings Participate in collaborative efforts (e.g., CRA, protocol development, and management, etc.) Participate in CRO and other vendor selection process and ongoing meetings Prepare study-related documents including Informed Consent Documents (ICD), patient instruction guides, review Case Report Forms (CRF,) and study oversight plan Track and presents study metrics including site activation, subject screening, and enrollment, CRF completion Assist in the development of site budgets and facilitate routine site budget negotiations Track that essential documents are received and maintained across assigned studies Knowledge and Skill Requirements Bachelor's degree, preferably in a scientific or health-related discipline Minimum of 3 to 6 years of clinical and related experience with at least 2 years of clinical trial management experience in an industry setting such as a CRO or pharmaceutical company Trial management experience gained at academic or other not-for-profit institutions involved in industry-sponsored research may supplement this requirement at the discretion of the hiring manager Exceptional understanding of GCP, ICH, FDA, EMA, and GDPR regulations Clinical experience/background (e.g., RN, PA, or medical office) also a plus Demonstrated ability to develop positive working relationships with individuals and teams both inside and outside the company Must have proficiency with MS Office as well as demonstrated ability to learn other project management and clinical trial software as required Demonstrated ability to work independently, escalate issues appropriately, and ensure a solutions-oriented approach to the identification and mitigation of risks to project milestones, budgets, and quality What We Offer A culture inspired by our values: (e.g., patients first, teamwork, scientific rigor and curiosity) A collaborative, data-driven pre-IPO start-up environment where we inspire each other to always perform at our best and focus on advancing science that will help patients Learning and development resources to help you grow professionally and potential for advancement for stronger performers Competitive compensation (Base & Performance Bonus) and stock option package (equity in an early-stage company) Rich medical, dental, and vision insurance plans Health, Limited, and Dependent Care FSA; HSA with company contributions 401(k) with company matching Pre-Tax Commuter Benefits Paid Term Life and AD&D, STD, and LTD plans Employee Assistance Program (EAP) Generous company paid holidays and flexible PTO Flexible work schedule (on-site/hybrid) Kitchen stocked with a variety of healthy and delicious snacks and drinks Free electric car charging on site The salary range for this position is $125,000 - 140,000. Nuvig considers various factors when determining the base compensation, including market survey data, experience, qualifications, and geographic location, which means that the actual compensation will vary. About Nuvig Nuvig Therapeutics, Inc., headquartered in Redwood City, California, is a science-driven research and clinical development organization focused on fundamentally transforming how we approach and treat inflammatory and autoimmune diseases. Our first product candidate NVG-2089 is a recombinant, human IgG1 Fc fragment that has been engineered to target immunomodulatory Type 2 Fc receptors and modulate immune response. Additional efforts are focused on engineering full-length therapeutic antibodies to maximize their ability to control aggressive autoimmune diseases. Founded in 2021 by industry experts, Nuvig Therapeutics is well-supported by top tier investors, ensuring robust funding to drive our innovative research and clinical programs forward. Key investors include Novo Holdings, Platanus, Bristol Myers Squibb, Digitalis Ventures, and Mission BioCapital. If your life and career ambitions are to advance transformative medicines that redefine treatment paradigms, please take a look at our job openings. If you think you would be a good fit for our team, please apply.

W2 Contract Salary Range: $83,200 - $104,000 per year As an Associate Clinical Scientist, you will work with cross-functional teams and senior-level scientists to design, execute, and monitor multiple clinical studies. You will be responsible for discrete data review, interpretation, and communication tasks to internal and external stakeholders. Oncology and early-stage development experience is highly preferred. You may be required to travel up to 20% of the role. Duties and Responsibilities: Data validation: Check data against predefined criteria and validation rules to identify discrepancies, errors, and missing values. Data reconciliation: Compare data across different sources, including CRFs, lab data, and eligibility packets, to ensure consistency and accuracy. Query management: Generate and resolve queries to clarify or correct data discrepancies. Data standardization: Ensure data is formatted consistently according to protocol specifications and regulatory standards (e.g., CDISC and SDTM). Audit trails and documentation: Maintain detailed data changes and justification records, ensuring traceability and GCP compliance. Contribute to developing program-level documents, including clinical protocols, investigator's brochure, clinical study reports, abstracts and manuscripts, presentations, and other internal and external documents and communications as needed. Prepare and conduct quality control checks of summaries of clinical data to internal and external stakeholders. Ensure trial implementation follows protocol and analyze information to assess protocol conduct or individual subject safety issues. Interact with internal and external stakeholders, including investigators, study sites, vendors, and committees, to support clinical trial objectives; respond to or triage questions for appropriate escalation. Conduct literature reviews as needed. Requirements and Qualifications: Master's degree or higher in a scientific discipline or other relevant advanced degree in a health science field. Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment. Detail-oriented with the ability to prioritize tasks and function independently as appropriate. Strong organizational skills and an ability to interpret, discuss, and report trial/program level data effectively and identify trends. Proficient with software tools (Microsoft Office, including Excel and Word), Electronic Data Capture, and other custom web-based software. Excellent written and verbal communication skills. Able to travel up to 20%. Desired Skills and Experience Clinical Development, Oncology, data validation, data reconciliation, query management, data standardization, CDISC, SDTM, cGCP, Excel, Word, Electronic Data Capture, travel Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at *************************

Are you an experienced Clinical Research Coordinator looking to set your roots down with a company that has room for career growth? Then this may be the perfect opportunity for you. In this role you will lead complex neurology based trials and have the opportunity to mentor fellow CRCs as well, and manage the research unit. This is a wonderful opportunity for CRCs with similar experience, looking to utilize their skills to their full potential. Open to candidates relocating or local! Summary: The Lead CRC is the subject matter expert and leader of a clinical trial team to conduct and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and company SOPs. Role & Responsibilities: Serve as leader of a study team to execute clinical trials Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills Create training strategies and mitigation plans Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and company SOPs Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports. Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols. Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries Ensure confidentiality of patient protected health information, sponsor confidential information and company confidential information is maintained by all team members Develop communication and escalation strategies within teams to that ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and company SOPs Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner Ensure staff are delegated and trained appropriately and documented Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements. Evaluate potential subjects for participation in clinical trials including phone and in person prescreens. Create and execute recruitment strategies in conjunction with patient recruitment staff Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol. Incorporate understanding of how decisions affect the bottom-line including links between operations and company's financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol. Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol Develop Quality Control strategies for team member projects Promote respect for cultural diversity and conventions with all individuals. Understand the disease process or condition under study Other duties as assigned Benefits: Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances) Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).) 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1) Short Term Disability Insurance Term Life Insurance Plan Further Information: We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA). This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.

Title: Clinical Trial Coordinator Contract to Hire: 6-month contract Responsibilities: Assist in operational and administrative research support under the clinical direction of the Principal Investigator (PI) Ensure compliance with institutional, federal, and sponsor regulations (e.g., FDA, IRB) Maintain accurate and up-to-date regulatory documents and study records Obtain informed consent from study participants under investigator supervision. Schedule and coordinate participant visits and follow-ups. Requirements: High School Diploma ~1 year of experience working in clinical trials Strong Organizational and Communication skills Ability to work effectively on cross-functional teams Prior experience in a Clinical Trials setting is highly preferred

Tata Elxsi brings together the best technology and user-centric design expertise to help customers deliver innovative solutions and great consumer experiences. Our integrated Design and Technology teams help enterprises reimagine their products and services - from strategy, consumer research and insights, to service and experience design, technology implementation, integration, launch, and beyond. We are looking for an experienced In-Person Moderator with a strong background in data collection, photography, and videography. This role will involve moderating participants and collecting high-quality images and videos at various residential locations across multiple cities. This is a field-based, temporary contract position that requires travel within the USA. Key Responsibilities: Data Collection & Quality Assurance: • Capture and document high-quality images and videos, ensuring they meet study guidelines and protocol. • Review and validate collected data on-site, ensuring clarity, accuracy, and proper documentation before uploading. • Organize and label all data files according to project specifications. In-Person Moderation: • Lead participant onboarding, providing clear instructions about the study and expectations for data collection. • Ensure that all participants follow the data collection protocol and address any questions or concerns during the process. • Maintain positive and professional communication with participants throughout the study. Adept at prioritizing research activities to deliver practical insights and direction quickly Understand the needs, challenges during the moderation and mitigate the same Site Preparation & Setup: • Set up and test data collection equipment (e.g., cameras, tablets, mobile devices) at each site before sessions begin. • Ensure all equipment is functioning properly and address any technical issues on-site. Logistics & Travel: • Travel between data collection sites across the USA, arriving on time and fully prepared for each session. • Organize logistics to ensure smooth transitions between sites, including necessary travel arrangements and accommodation. • Remain flexible to accommodate changes in travel or collection schedules based on study needs. Equipment Management: • Safely operate and maintain data collection equipment, ensuring proper functionality. • Troubleshoot minor technical issues on-site and report any significant issues to the project manager. • Prior experience in photography or videography is required, with an understanding of camera operation, framing, lighting, and video capture. • Experience with field-based data collection • Expertise designing and executing evaluative research studies to assess digital experiences • Experience moderating in- person, remote/virtual research with research participants (e.g., interviews, usability testing) • Expertise in survey design Qualifications and Skills: Experience: • Prior experience in photography or videography is required, with an understanding of camera operation, framing, lighting, and video capture. • Experience with field-based data collection is a plus. • Experience with field-based data collection • Expertise designing and executing evaluative research studies to assess digital experiences • Experience moderating in- person, remote/virtual research with research participants (e.g., interviews, usability testing) • Expertise in survey design. Skills & Competencies: • Attention to Detail: Ability to ensure data accuracy, clarity, and adherence to project protocols. • Communication Skills: Strong interpersonal skills for moderating participants and ensuring clear communication of guidelines. • Technical Proficiency: Comfortable using various data collection tools such as cameras, tablets, and mobile devices. • Photography/Videography Skills: A demonstrated interest or experience in capturing high-quality images and videos with an understanding of technical and aesthetic standards. • Has computer trouble shooting experience, • Handling hardware and software trouble shooting • Organizational Skills: Ability to keep track of collected data and ensure everything is properly stored, labeled, and uploaded. • Problem Solving: Ability to identify and resolve minor technical and logistical issues on-site. Other Requirements: • Ability to travel and work across various US cities; occasional overnight stays may be required. • Flexible schedule with possibility of working in night shift and the ability to work 5 days a week, including potential extended hours depending on data collection needs. Tata Elxsi offers a comprehensive compensation and benefits package. Tata Elxsi is an affirmative action-equal opportunity employer. Tata Elxsi complies with all applicable federal, state and local laws regarding recruitment and hiring. All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, citizenship status, disability, protected veteran status, or any other category protected by applicable federal, state or local laws. Tata Elxsi does not currently require partners or employees to be fully vaccinated or test negative for COVID-19 in order to go to Tata Elxsi offices, client sites or Tata Elxsi events, except when mandated by federal, state or local law. In some circumstances, clients also may require proof of vaccination or testing (e.g., to go to the client site). What are our perks for Full time employee? We provide unique options to fit your unique lives!. Our menu of flexible options includes, but is not limited to: • Excellent healthcare options: Medical, vision, prescription & dental • Family Focus & Balance: medical, commuters & Dependent FSA, Competitive PTO, Sick Time, and Employee Assistance Program • Financial Security: Competitive 401(k) match with Safe Harbor Plan, • Employee Recognition Programs • Perks AT works: Our exclusive one-stop online discount marketplace

Job title: Sr Clinical Trial Manager About Us About SiteOne SiteOne Therapeutics is a biopharmaceutical company developing treatments for hypersensitivity disorders of the nervous system such as pain, cough and epilepsy. Our values are scientific rigor, intensity, teamwork and commitment to our shared mission of developing transformative medicines for the benefit of patients. Our drug candidates are exquisitely selective modulators of ion channels, and are under investigation by both systemic and local routes of administration. An opportunity is currently available for a talented and motivated individuals to join our team. Hybrid and remote options are available. Key Responsibilities We are seeking an accomplished and results-driven Senior Clinical Trials Manager who will be responsible for: Clinical operations functional activities related to the execution of assigned clinical trials based upon department and corporate goals and objectives. Management of clinical studies and vendors to ensure studies are completed on time, within budget and in compliance with Standard Operating Procedures (SOPs), FDA regulations and International Council for Harmonization (ICH)/ GCP guidelines. Identify, engage, and manage the activities of clinical CROs and other clinical study providers (e.g., central labs, study specific vendors, independent contractors) to execute clinical trials. Reviewing and contributing to the development of study-specific documentation including clinical trial protocols, informed consent forms, case report forms, and study guides/manuals. Reviewing monitoring reports and other study documentation as required. Oversight of the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF). Lead study management team meetings and collaborate with other functional groups within the company (e.g., Clinical Research, Biometrics, Clinical Supply, Regulatory, QA, Finance, Legal, etc.) to achieve clinical study goals. Following up on assigned team action items and identification, escalation, and resolution of issues as needed. Conduct in-person or remote site visits (e.g., training visits, site initiation visits, monitoring visits), as required. Qualifications BA/BS required with a minimum of 6 years of industry experience in clinical operations within the biopharmaceutical industry: Experience in managing Phase 1-3 clinical studies that relies on clinical outsourcing Leading internal and external teams, including CROs, vendors, and consultants Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team. Must display strong organizational, analytical and problem-solving skills at a project level and collaborate with colleagues to generate solutions Strong communication and influence skills and ability to create a clear sense of direction Ability to deal with time demands or unexpected events and escalate, when appropriate Knowledgeable of FDA, EMA, ICH and GCP regulations and guidelines Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities Ability to travel as required for the program (25%)

Job Title: Senior Clinical Trial Associate Key Responsibilities: Assist in the planning, coordination, and execution of clinical trials, ensuring they are conducted in compliance with the protocol, SOPs, GCP, and regulatory requirements. Support clinical project teams in managing and tracking study progress, identifying and resolving issues proactively. Liaise with CROs, clinical investigators, and other study team members to ensure effective communication and smooth study execution. Prepare and review regulatory documentation, including informed consent forms, study reports, and ethics committee submissions. Coordinate and track site activities, including site selection, initiation, monitoring, and close-out. Manage study supplies and inventory, ensuring timely availability for clinical sites. Assist in the preparation of Clinical Trial Management System (CTMS) documentation and reporting. Support data collection, review, and management to ensure high-quality data is available for analysis. Contribute to study risk management and assist in ensuring timelines and milestones are met. Support the clinical team in the preparation and review of investigator brochures, clinical study reports, and other study documentation. Assist with preparation for regulatory inspections and audits. Qualifications: Bachelor's degree in a related field (e.g., Life Sciences, Nursing, or equivalent experience). Minimum 2.5 years of experience in clinical trial management with a biotech sponsor. Strong knowledge of Good Clinical Practice (GCP) and FDA regulations. Experience in managing or supporting clinical trials across multiple sites and regions. Strong communication and organizational skills with the ability to manage multiple priorities. Ability to work independently and collaboratively in a team environment. Strong attention to detail and problem-solving skills. Additional Details: Onsite presence required 2x per week at our South San Francisco location. Competitive salary and benefits package. Opportunity to work in a dynamic, fast-paced biotech environment with growth potential. If you have a passion for rare disease clinical trials and want to contribute to advancing cutting-edge biotech solutions, we encourage you to apply!

Research Associate/Senior Research Associate - Immunology & Murine Disease Modeling A dynamic and innovative biotech company is seeking a skilled Research Associate or Senior Research Associate to join its research and development team. This role offers an exciting opportunity to contribute to groundbreaking work in immunology and age-related diseases while growing as a researcher and leader. The position involves designing and executing critical experiments in a fast-paced and collaborative environment. Key Responsibilities Conduct in vivo animal studies, including models such as bleomycin-induced lung fibrosis and metabolic-related diseases like high-fat diet-induced diabetes. Perform animal research procedures, including monitoring, dosing, necropsy, and organ collection, to support target validation, mechanism of action studies, and immune analysis using ELISAs and flow cytometry. Assist in experimental design, execution, data analysis, and reporting. Qualifications & Skills B.S. in biology or a related field with 3-7 years of industry experience in rodent models of lung disease (preference for bleomycin-induced lung fibrosis, but experience with asthma/COPD models is also valuable). Strong background in animal handling with proficiency in various in vivo dosing techniques (i.v., intratracheal, i.p., s.c., i.n., p.o.), as well as organ and blood collection/dissection methods. Ability to support IACUC submissions, study design, execution, and data analysis with strong presentation skills. Experience in immunoassays such as ELISAs and flow cytometry is advantageous. Proficiency in software tools like Excel, Word, PowerPoint, and Prism. Strong organizational skills, teamwork mindset, and adaptability to a fast-paced biotech startup environment. Compensation & Benefits This position offers a competitive salary stock options, and a comprehensive benefits package, along with a monthly stipend for wellness activities. The company is committed to fostering career growth through professional development opportunities, including online courses, seminars, and conferences. The organization values diversity and welcomes applications from individuals of all backgrounds.

W2 Contract Salary Range: $83,200 - $104,000 per year As an Associate Clinical Scientist, you will work with cross-functional teams and senior-level scientists to design, execute, and monitor multiple clinical studies. You will be responsible for discrete data review, interpretation, and communication tasks to internal and external stakeholders. Oncology and early-stage development experience is highly preferred. You may be required to travel up to 20% of the role. Duties and Responsibilities: Data validation: Check data against predefined criteria and validation rules to identify discrepancies, errors, and missing values. Data reconciliation: Compare data across different sources, including CRFs, lab data, and eligibility packets, to ensure consistency and accuracy. Query management: Generate and resolve queries to clarify or correct data discrepancies. Data standardization: Ensure data is formatted consistently according to protocol specifications and regulatory standards (e.g., CDISC and SDTM). Audit trails and documentation: Maintain detailed data changes and justification records, ensuring traceability and GCP compliance. Contribute to developing program-level documents, including clinical protocols, investigator's brochure, clinical study reports, abstracts and manuscripts, presentations, and other internal and external documents and communications as needed. Prepare and conduct quality control checks of summaries of clinical data to internal and external stakeholders. Ensure trial implementation follows protocol and analyze information to assess protocol conduct or individual subject safety issues. Interact with internal and external stakeholders, including investigators, study sites, vendors, and committees, to support clinical trial objectives; respond to or triage questions for appropriate escalation. Conduct literature reviews as needed. Requirements and Qualifications: Master's degree or higher in a scientific discipline or other relevant advanced degree in a health science field. Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment. Detail-oriented with the ability to prioritize tasks and function independently as appropriate. Strong organizational skills and an ability to interpret, discuss, and report trial/program level data effectively and identify trends. Proficient with software tools (Microsoft Office, including Excel and Word), Electronic Data Capture, and other custom web-based software. Excellent written and verbal communication skills. Able to travel up to 20%. Desired Skills and Experience Clinical Development, Oncology, data validation, data reconciliation, query management, data standardization, CDISC, SDTM, cGCP, Excel, Word, Electronic Data Capture, travel Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at *************************

Title: Clinical Trial Coordinator Contract to Hire: 6-month contract Responsibilities: Assist in operational and administrative research support under the clinical direction of the Principal Investigator (PI) Ensure compliance with institutional, federal, and sponsor regulations (e.g., FDA, IRB) Maintain accurate and up-to-date regulatory documents and study records Obtain informed consent from study participants under investigator supervision. Schedule and coordinate participant visits and follow-ups. Requirements: High School Diploma ~1 year of experience working in clinical trials Strong Organizational and Communication skills Ability to work effectively on cross-functional teams Prior experience in a Clinical Trials setting is highly preferred

Research Associate/Senior Research Associate - Immunology & Murine Disease Modeling A dynamic and innovative biotech company is seeking a skilled Research Associate or Senior Research Associate to join its research and development team. This role offers an exciting opportunity to contribute to groundbreaking work in immunology and age-related diseases while growing as a researcher and leader. The position involves designing and executing critical experiments in a fast-paced and collaborative environment. Key Responsibilities Conduct in vivo animal studies, including models such as bleomycin-induced lung fibrosis and metabolic-related diseases like high-fat diet-induced diabetes. Perform animal research procedures, including monitoring, dosing, necropsy, and organ collection, to support target validation, mechanism of action studies, and immune analysis using ELISAs and flow cytometry. Assist in experimental design, execution, data analysis, and reporting. Qualifications & Skills B.S. in biology or a related field with 3-7 years of industry experience in rodent models of lung disease (preference for bleomycin-induced lung fibrosis, but experience with asthma/COPD models is also valuable). Strong background in animal handling with proficiency in various in vivo dosing techniques (i.v., intratracheal, i.p., s.c., i.n., p.o.), as well as organ and blood collection/dissection methods. Ability to support IACUC submissions, study design, execution, and data analysis with strong presentation skills. Experience in immunoassays such as ELISAs and flow cytometry is advantageous. Proficiency in software tools like Excel, Word, PowerPoint, and Prism. Strong organizational skills, teamwork mindset, and adaptability to a fast-paced biotech startup environment. Compensation & Benefits This position offers a competitive salary stock options, and a comprehensive benefits package, along with a monthly stipend for wellness activities. The company is committed to fostering career growth through professional development opportunities, including online courses, seminars, and conferences. The organization values diversity and welcomes applications from individuals of all backgrounds.

Title: Clinical Trial Coordinator Contract to Hire: 6-month contract Responsibilities: Assist in operational and administrative research support under the clinical direction of the Principal Investigator (PI) Ensure compliance with institutional, federal, and sponsor regulations (e.g., FDA, IRB) Maintain accurate and up-to-date regulatory documents and study records Obtain informed consent from study participants under investigator supervision. Schedule and coordinate participant visits and follow-ups. Requirements: High School Diploma ~1 year of experience working in clinical trials Strong Organizational and Communication skills Ability to work effectively on cross-functional teams Prior experience in a Clinical Trials setting is highly preferred