Senior Clinical Trial Associate

4 days ago

San Francisco, California, United States Meet Full time
Job Summary

We are seeking a highly skilled and experienced Senior Clinical Trial Associate to join our Clinical Operations team. As a key member of our team, you will play a critical role in supporting the successful execution of clinical trials.

Key Responsibilities
  • Conduct site feasibility assessments and recruitment efforts, ensuring that clinical documents are clear, accurate, and compliant with ICH/GCP guidelines.
  • Review and oversee study plans, including Clinical Monitoring, Communication, Project Management, and electronic Trial Master File (eTMF) Management.
  • Audit data fields within electronic data capture (EDC) systems and compile/download reports to aid in study management and data review.
  • Participate in user acceptance testing (UAT) of clinical systems, such as EDC and interactive response technology (IRT), and may assist in authoring system requirements.
  • Monitor and track essential regulatory documentation from clinical sites both before and during study conduct.
  • Review site-specific Informed Consent Forms (ICFs).
  • Assess Site Visit Reports for accuracy, quality, and consistency.
  • Assist in managing study vendors.
  • Support TMF quality control and address reconciliation findings.
Qualifications
  • Typically requires a minimum of 3 years of relevant experience or a combination of experience and education/training (e.g., Clinical Trials Design and Management Certificate).
Preferred Education
  • Bachelor's degree in biological sciences, health care management, or life sciences research; BSN/RN or experience in clinical trial management.
Preferred Experience
  • Solid understanding of the Trial Master File (TMF) structure, particularly the DIA model.
  • Strong written and verbal communication skills with proven multitasking abilities.
  • Effective time management and organizational skills.
  • High attention to detail and accuracy.
Preferred Computer Skills
  • Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and other electronic clinical technologies.
Location

This position is based in South San Francisco, CA, with an expectation of being in the office 3 days a week, Tuesday through Thursday. Remote applicants will not be considered at this time.

  • Senior Clinical Trial Associate

    5 days ago

    San Francisco, California, United States Meet Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Trial Associate to join our Clinical Operations team. As a key member of our team, you will play a critical role in supporting the successful execution of clinical trials.Key ResponsibilitiesConduct site feasibility assessments and recruitment efforts, ensuring timely and accurate data...

  • Senior Clinical Trials Manager

    3 days ago

    San Francisco, California, United States Meet Full time

    Meet the Challenge of Groundbreaking Oncology Research **Senior Clinical Trial Manager - SF Bay Area Oncology** We are seeking an experienced Senior Clinical Trial Manager to lead our clinical trials in oncology research. As a key member of our team, you will work closely with cross-functional teams and external partners to ensure the successful execution...

  • Senior Clinical Trial Manager

    6 days ago

    San Francisco, California, United States Meet Full time

    Senior Clinical Trials Manager - Oncology ResearchMeet a rapidly growing biotech company focused on developing innovative oncology treatments. This company fosters a collaborative environment, allowing for high levels of professional growth and development. The team is seeking an experienced Senior Clinical Trials Manager to lead their clinical trials,...

  • Senior Financial Analyst

    6 days ago

    San Francisco, California, United States Trial Library Full time

    Our mission is to improve health equity by expanding access to cancer precision medicine.Trial Library, Inc. is a venture-backed startup founded to address inequities in clinical trial participation. Our technology is integrated with human-led navigation to enable clinical trial discovery for anyone, anywhere. Our vision is to be the leading discovery and...

  • Senior Clinical Trial Manager

    2 months ago

    South San Francisco, California, United States Annexon, Inc. Full time

    Position SummaryThe Senior Clinical Trial Manager / Associate Director, Clinical Operations (Ophthalmology) is responsible for the operational management, oversight and execution of one or more clinical trials including CROs, vendors, and consultants as needed for the conduct of clinical studies. This individual will report to the Executive Director,...

  • Senior Clinical Operations Associate

    6 days ago

    San Francisco, California, United States Meet Full time

    Job SummaryThe Senior Clinical Operations Associate will report to the Head of Clinical Operations and will be responsible for assisting in the oversight and management of clinical trial execution. The Senior Clinical Operations Associate will maintain oversight over Contract Research Organizations (CROs) and key study Contract Service Providers (CSPs) to...

  • Senior Clinical Research Coordinator

    6 days ago

    San Francisco, California, United States US Tech Solutions Full time

    Job SummaryUS Tech Solutions is seeking a highly skilled Senior Clinical Research Coordinator to join our team. As a key member of our clinical research team, you will be responsible for coordinating and managing clinical trials from start to finish.Key ResponsibilitiesOn-Site Coordination: Provide daily on-site support to our primary research site, ensuring...

  • Clinical Trial Manager/Senior Clinical Trial Manager

    2 months ago

    San Francisco, California, United States Nurix Therapeutics Full time

    Nurix is seeking a Clinical Trial Manager (CTM)/Sr. CTM to join the Clinical Operations team. This individual will be responsible for management of global regions and/or clinical programs. They will lead study team, vendors, clinical monitors and clinical sites throughout the life cycle of a clinical trial.This individual will be able to manage clinical...

  • Clinical Trial Oversight Manager

    3 weeks ago

    South San Francisco, California, United States Meet Full time

    Position OverviewThe Senior Clinical Operations Associate will collaborate closely with the Head of Clinical Operations to facilitate the effective management and oversight of clinical trials. This role involves ensuring the integrity of trial execution and data collection while working in partnership with key study sites and investigators. The Senior...

  • Community Practice Clinical Data Coordinator

    2 months ago

    San Francisco, California, United States Trial Library Full time

    Our mission is to improve health equity by expanding access to cancer precision medicine.Our vision is to be the leading discovery and recruitment platform for inclusive clinical trials.The Community Practice Clinical Data Coordinator at Trial Library will play an integral part in expanding access to cancer clinical trials by pioneering pre-screening efforts...

  • Clinical Trial Associate

    1 month ago

    San Diego, California, United States Actalent Full time

    Clinical Trial Associate II Job Description As a Clinical Trial Associate, you will be providing support and managing the trial status to ensure efficient trial management. Your primary responsibilities will include maintaining the eTMF, assisting with its setup and maintenance, and ensuring its readiness for audits/inspections. You will also assist with the...

  • Lead Financial Analyst

    3 weeks ago

    San Francisco, California, United States Trial Library Full time

    About Trial Library, Inc.Our mission is to enhance health equity by broadening access to cancer precision medicine. Founded in 2022, Trial Library, Inc. is a venture-backed startup dedicated to tackling disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for...

  • Lead Financial Analyst

    3 weeks ago

    San Francisco, California, United States Trial Library Full time

    About Trial Library, Inc.Our mission is to enhance health equity by broadening access to cancer precision medicine. Trial Library, Inc. is a venture-backed startup established to tackle disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for everyone, regardless of...

  • Lead Financial Analyst

    3 weeks ago

    San Francisco, California, United States Trial Library Full time

    About Trial Library, Inc.Our mission is to enhance health equity by broadening access to cancer precision medicine. Founded in 2022, Trial Library, Inc. is a venture-backed startup dedicated to addressing disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for...

  • Lead Financial Analyst

    3 weeks ago

    San Francisco, California, United States Trial Library Full time

    Our mission is to enhance health equity by broadening access to cancer precision medicine.Trial Library, Inc. is a venture-backed startup established to tackle disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for individuals everywhere. Our aspiration is to become...

  • Lead Financial Analyst

    3 weeks ago

    San Francisco, California, United States Trial Library Full time

    Our mission is to enhance health equity by broadening access to cancer precision medicine.Trial Library, Inc. is a startup supported by venture capital, established to tackle disparities in clinical trial participation. Our innovative technology, combined with human-led navigation, facilitates clinical trial discovery for everyone, regardless of location....

  • Clinical Trials Senior Manager for LUMUS Program

    2 weeks ago

    South San Francisco, California, United States Alumis Full time

    Position OverviewSalary: Alumis Inc. is dedicated to precision medicine, aiming to enhance the lives of individuals suffering from autoimmune disorders. Despite advancements in treatment over the past twenty years, numerous patients with immunologic conditions still face challenges. Our mission is to significantly improve outcomes for these patients. We are...

  • Senior Clinical Oversight Specialist

    3 weeks ago

    San Diego, California, United States Clinical Dynamix Full time

    The Senior Clinical Oversight Specialist plays a crucial role in the clinical research landscape, serving as the primary liaison for clinical research sites. This remote position involves conducting qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the CRO...

  • Clinical Trial Operations Associate

    3 weeks ago

    South San Francisco, California, United States Allogene Therapeutics Full time

    Job OverviewAbout Allogene:Allogene Therapeutics, located in South San Francisco, is at the forefront of biotechnology, specializing in the innovative development of allogeneic chimeric antigen receptor T cell (AlloCAR TTM) therapies aimed at treating cancer and autoimmune disorders. Our experienced leadership team is dedicated to creating a pipeline of...

  • Senior Clinical Oversight Specialist

    3 weeks ago

    San Diego, California, United States Clinical Dynamix Full time

    The Senior Clinical Oversight Specialist is a remote, field-based position responsible for offering support to clinical research sites as the primary liaison for the study. This role involves conducting qualification and site initiation visits on behalf of the sponsor, as well as performing quality oversight assessments to evaluate the performance of the CRO...