Clinical Coordinator Jobs in South San Francisco, CA

Hi, My name is Gaurav and I am a recruiter with Net2Source Inc. Our direct client is looking to hire a Vendor Outsourcing Associate I in their growing team. Please find below the job description. True Job Title: Vendor Outsourcing Associate I Location: Foster City, CA Hybrid: 3 days a week minimum Contract Duration: 12 months with possible extension ***** is looking for a Vendor Outsourcing, QC Specialist who will report to the Senior Manager of Vendor Outsourcing (VO). The candidate will be responsible for conducting functional internal audits on behalf of Vendor Outsourcing to ensure inspection readiness. This position will also be responsible for assisting in business process improvement initiatives to maximize quality and efficiencies. The VO QC Specialist is expected to complete tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently. Demonstrates a thorough knowledge of Good Clinical Practice “GCP”, Good Pharmacovigilance Practices “GVP”, Good Laboratory Practice “GLP”, Good Documentation Practice “GDP” and ICH E6 R2 compliance requirements. Demonstrates a thorough understanding of current global and regional trends in compliance. Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.(1) PMP certification or equivalent certification, (2) Candidates can be current or former project managers & (3) Project management experience in Pharmaceutical or Healthcare industries Skills: • Strong interpersonal communication skills • Attention to detail and proactive management of quality findings will be integral to the team's success • Strong project management, organization, and critical thinking skills • Comfortable interacting with internal stakeholders and external vendors • Executive presence Top 3 Required Skill Sets: (1) Vendor Outsourcing (2) Candidates can be current or former project managers (3) Deep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries Top 3 Nice to Have Skill Sets: (1) Quality and Compliance (2) Vendor Contracting (3) R&D Clinical MUST: Great attention to detail, Growth Mindset, Proactive Leader to drive initiatives, Strong written and Verbal Communication skills, Passionate, and Able to thrive in a dynamic work environment. Thanks Gaurav Gupta Sr. Pharma Recruiter *************************** **************

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: 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!

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%)

Host Healthcare is seeking a local contract nurse RN Clinical Nurse Coordinator for a local contract nursing job in Castro Valley, California. Job Description & Requirements Specialty: Clinical Nurse Coordinator Discipline: RN Start Date: 03/24/2025 Duration: 13 weeks 40 hours per week Shift: 8 hours, days Employment Type: Local Contract Host Healthcare is an award-winning travel healthcare company with an immediate opening for this Registered Nurse - Emergency Room in Castro Valley, CA. If you are interested in this position, please contact your recruiter and reference Job #2006399 Why choose Host Healthcare? Because a great Host provides a worry-free travel experience and always puts your needs first. Our passionate and transparent team members have made Host Healthcare the #1 ranked Travel Healthcare company in the U.S. Our recruiters act not only as your dedicated travel career mentor but also as your #1 advocate. When you work with us, you can trust that we will help you with everything from travel, to housing, and acting as a liaison between you and the facility. We've got your back! Travel Happy With Host Healthcare We offer the best pay for our travelers Day one medical, dental, and vision insurance License, travel, tuition, and scrub reimbursement Matching 401k Deluxe private housing or generous housing stipend Discounts to your favorite activities, restaurants, health & beauty brands, shopping and hotels Host Healthcare Job ID #La1fVJ0000059yBlYAI. Pay package is based on 8 hour shifts and 40 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: RN - Nurse Navigator About Host Healthcare At Host Healthcare, we provide a truly comfortable experience as you explore your travel nursing, therapy, or allied career. We make your travel healthcare journey easy by taking care of all the details, so you don't have to. We are on a mission to help others live better and we do this by helping the healers of the world be as comfortable as possible. With access to tens of thousands of travel nursing, therapy, and allied jobs in all 50 states, our responsive and friendly recruiters find your dream position based on what's important to you. During your assignment, get access to premium benefits, including Day 1 medical that continues up to 30 days between assignments, 401K matching, travel reimbursements, dedicated housing support, and more. We also offer 24/7 support from our team and access to our on-staff clinicians so you can feel comfortable and confident throughout your entire assignment. Travel comfortably with Host Healthcare. Benefits Referral bonus School loan reimbursement Vision benefits Wellness and fitness programs Company provided housing options License and certification reimbursement Life insurance Medical benefits Mileage reimbursement Pet insurance Discount program Employee assistance programs Guaranteed Hours Health savings account Holiday Pay 401k retirement plan Continuing Education Dental benefits

Direct Hire Full-Time Role Salary Range: $154,000 - $175,000 per year Duties and Responsibilities: Independently manage the full scope of study conduct (start-up through database lock) and coordinate cross-functional efforts to achieve study objectives and goals of complex studies (global Phase 1 and beyond) Collaborate cross-functionally to meet corporate goals. Act as a technical expert in clinical study management. Be responsible for the operational oversight of multiple clinical studies. Act as the global lead for a complex study(ies). Lead a Study Management Team (SMT). Be accountable for accurately reporting clinical study details in weekly side-by-side review slides. May have direct reports. Lead a Study Management Team. Perform the activities of planning, implementing, monitoring, and managing clinical trials. Participate in designing and developing clinical trial protocols, informed consent, case report forms, CRF completion guidelines, and Source documents as applicable. Work with Medical Affairs/Medical Monitor to select investigative sites, train investigators and investigative site staff, prepare materials for site initiation visits/investigator meetings, oversee clinical supplies, etc. May supervise and mentor CTMs, CRAs, and other operational personnel. Partner with the Contract Management and Outsourcing teams to develop vendor agreements, change orders, and site-specific budget templates. Manage and oversee external partners, consultants, vendors, and budgets to ensure the timely and cost-effective implementation of assigned projects. Be responsible for reviewing invoices for accuracy compared to work known to be performed by the vendors. May contribute to broader organization goals/or activities as assigned. May facilitate the selection of multiple vendors/or complex service providers in partnership with the Contract Management and Outsourcing team. May be responsible for implementing and managing the quality and performance management framework across assigned studies within a program, including vendor oversight activities. Identify potential risks that may impact the study(ies), e.g., study data, ethical conduct, and adherence to ICH guidelines, and provide risk mitigation solutions. Independently manage the full scope of the various stages of study activities, e.g., start-up, treatment, maintenance, and close-out, to ensure the study is conducted on time and within budget. Understand the data requirements of the clinical study(ies) to ensure the quality and integrity of data during collection, review, cleaning, and monitoring. Collaboratively make key decisions relating to vendors, sites, and overall study strategy. Be accountable for study timelines and quality metrics related to subject safety, data quality, and study integrity. Mentor and develop team and deliver performance reviews. Help to train people from CTA level to Sr. CRA/CTM. Perform duties with minimal supervision and partner with other team members to complete deliverables on time. Requirements and Qualifications: BS/BA in Life Science or related discipline 6+ years of clinical operations experience or related drug development 2+ years at a sponsor company 1+ years as global study lead Familiar with FDA & ICH/GCP regulations and guidelines and the process of all stages of clinical development from trial design to completion Proficient in computer skills and experience with Microsoft Office applications; demonstrated experience in technical writing Effective team player and exceptional written and interpersonal communication skills demonstrated an aptitude for strategic thinking skills. Demonstrated direct management experience as a study lead with vendors and clinical service providers, including CRO identification, selection, and management Ability to manage delegated aspects of assigned clinical trials Ability to influence and collaborate with cross-functional clinical study teams Strong clinical studies planning and organizational skills Demonstrated experience in technical writing, including clinical protocol, ICFs, and Study plans Able to utilize strong influencing skills with key stakeholders. Global clinical trial and CRO oversight management experience in oncology and/or ophthalmology Early-phase trial management experience is preferred. Desired Skills and Experience Clinical operations, drug development, FDA, ICH Guidelines, GCP, Microsoft Office, technical writing, study lead, CRO, vendor management, early-phase clinical trial Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at *************************

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.

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

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.

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. .

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.

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!

Direct Hire Full-Time Role Salary Range: $154,000 - $175,000 per year Duties and Responsibilities: Independently manage the full scope of study conduct (start-up through database lock) and coordinate cross-functional efforts to achieve study objectives and goals of complex studies (global Phase 1 and beyond) Collaborate cross-functionally to meet corporate goals. Act as a technical expert in clinical study management. Be responsible for the operational oversight of multiple clinical studies. Act as the global lead for a complex study(ies). Lead a Study Management Team (SMT). Be accountable for accurately reporting clinical study details in weekly side-by-side review slides. May have direct reports. Lead a Study Management Team. Perform the activities of planning, implementing, monitoring, and managing clinical trials. Participate in designing and developing clinical trial protocols, informed consent, case report forms, CRF completion guidelines, and Source documents as applicable. Work with Medical Affairs/Medical Monitor to select investigative sites, train investigators and investigative site staff, prepare materials for site initiation visits/investigator meetings, oversee clinical supplies, etc. May supervise and mentor CTMs, CRAs, and other operational personnel. Partner with the Contract Management and Outsourcing teams to develop vendor agreements, change orders, and site-specific budget templates. Manage and oversee external partners, consultants, vendors, and budgets to ensure the timely and cost-effective implementation of assigned projects. Be responsible for reviewing invoices for accuracy compared to work known to be performed by the vendors. May contribute to broader organization goals/or activities as assigned. May facilitate the selection of multiple vendors/or complex service providers in partnership with the Contract Management and Outsourcing team. May be responsible for implementing and managing the quality and performance management framework across assigned studies within a program, including vendor oversight activities. Identify potential risks that may impact the study(ies), e.g., study data, ethical conduct, and adherence to ICH guidelines, and provide risk mitigation solutions. Independently manage the full scope of the various stages of study activities, e.g., start-up, treatment, maintenance, and close-out, to ensure the study is conducted on time and within budget. Understand the data requirements of the clinical study(ies) to ensure the quality and integrity of data during collection, review, cleaning, and monitoring. Collaboratively make key decisions relating to vendors, sites, and overall study strategy. Be accountable for study timelines and quality metrics related to subject safety, data quality, and study integrity. Mentor and develop team and deliver performance reviews. Help to train people from CTA level to Sr. CRA/CTM. Perform duties with minimal supervision and partner with other team members to complete deliverables on time. Requirements and Qualifications: BS/BA in Life Science or related discipline 6+ years of clinical operations experience or related drug development 2+ years at a sponsor company 1+ years as global study lead Familiar with FDA & ICH/GCP regulations and guidelines and the process of all stages of clinical development from trial design to completion Proficient in computer skills and experience with Microsoft Office applications; demonstrated experience in technical writing Effective team player and exceptional written and interpersonal communication skills demonstrated an aptitude for strategic thinking skills. Demonstrated direct management experience as a study lead with vendors and clinical service providers, including CRO identification, selection, and management Ability to manage delegated aspects of assigned clinical trials Ability to influence and collaborate with cross-functional clinical study teams Strong clinical studies planning and organizational skills Demonstrated experience in technical writing, including clinical protocol, ICFs, and Study plans Able to utilize strong influencing skills with key stakeholders. Global clinical trial and CRO oversight management experience in oncology and/or ophthalmology Early-phase trial management experience is preferred. Desired Skills and Experience Clinical operations, drug development, FDA, ICH Guidelines, GCP, Microsoft Office, technical writing, study lead, CRO, vendor management, early-phase clinical trial 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.

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!

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