• Clinical Research Specialist

    Insight Global (Irvine, CA)


    Job Description

    A large medical device company is looking for a Clinical Research Specialist to support the planning, execution, and oversight of clinical research activities in compliance with regulatory requirements and company standards. This role is critical in ensuring high-quality site management and operational excellence across clinical trials. Key responsibilities include but are not limited to:

     

    Serve as the primary liaison between the sponsor and clinical trial sites, ensuring effective communication and collaboration.

     

    Oversee site management activities, including site initiation, monitoring, and close-out visits.

     

    Ensure compliance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.

     

    Perform data analysis and data review to ensure accuracy, completeness, and consistency of clinical trial data.

     

    Support the development and review of essential documents such as informed consent forms, monitoring plans, and site training materials.

     

    Track and report site performance metrics, addressing issues proactively to maintain study timelines.

     

    Collaborate with cross-functional teams (Regulatory, Data Management, Clinical Operations) to ensure smooth trial execution.

     

    Maintain accurate and timely documentation in clinical trial management systems (CTMS).

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

     

    Skills and Requirements

     

    1+ year of experience in clinical research within a sponsor company

     

    Strong experience with data analysis and data review

     

    Strong exposure to site management

     

    Bachelor's Degree