A medical device company located in Irvine, CA is looking for a Sr. Clinical Research Specialist to play a critical role in the design, execution, and management of clinical research studies. The responsibilities include but are not limited to:
Study Design and Planning: Develop and design clinical research protocols, ensuring alignment with regulatory requirements and company objectives.
Project Management: Oversee the execution of clinical trials, including site selection, patient recruitment, data collection, and monitoring.
Regulatory Compliance: Ensure all clinical research activities comply with FDA regulations, ICH-GCP guidelines, and other relevant regulatory standards.
Data Analysis and Reporting: Analyze clinical trial data and prepare comprehensive reports for internal and external stakeholders.
Vendor Management: Manage relationships with clinical sites and other external partners to ensure high-quality and timely execution of clinical studies.
Risk Management: Identify and mitigate potential risks associated with clinical trials to ensure patient safety and data integrity.
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.
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7+ years of experience in clinical research focused on medical device or pharmaceutical
Experience with site management
Experience with EDC and ETMF
Project management experience - finances, accruals, invoices from vendors
Bachelor's Degree
Benefit packages for this role will start on the 31st 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.