Clinical Research Specialist

7 days ago

Irvine, CA, United States Insight Global Full time

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 HR@insightglobal.com.To 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/.

Required Skills & Experience

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

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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