Job Summary:
Randstad Life Sciences is seeking an experienced Sr. Study Specialist to join their Global Study Operations (GSO) team in San Rafael, California. This full-time contract role involves overseeing critical aspects of site monitoring, vendor management, and clinical trial execution to ensure study quality, participant safety, data integrity, and regulatory compliance. Candidates with a strong background in clinical research, vendor oversight, and study documentation are encouraged to apply.
Key Responsibilities:
Develop and maintain study-specific documentation under Study Manager guidance.
Oversee country and site feasibility assessments and site selection processes.
Supervise CRO activities related to IRB/EC submissions and approvals.
Manage essential documents across the entire study life-cycle.
Create and review site and investigator training materials; present at investigator meetings.
Ensure accurate trial registration and updates on ClinicalTrials.gov.
Handle Screening Authorization Forms sign-off and tracking.
Process documentation via DocuSign.
Oversee Clinical Trial Insurance processes.
Represent GSO in global, vendor, and cross-functional meetings; record meeting minutes.
Maintain Trial Master File (TMF) integrity and completeness.
Identify and mitigate operational risks in global study execution.
Provide administrative support for internal/external meetings.
Required Skills & Qualifications:
Bachelor’s degree (BA/BS) or higher in Nursing, Life Sciences, or related fields. Relevant industry experience may substitute formal education.
Proven experience in clinical study management within biotech or pharmaceutical environments.
Expertise in CRO/vendor oversight, including SOW, budgeting, POs, and invoice processing.
Familiarity with Clinical Trial Management Systems (CTMS).
Strong knowledge of drug development and study design.
Excellent leadership, communication, and collaboration skills.
Ability to prioritize tasks in a fast-paced environment and deliver high-quality outcomes.
Perks & Benefits:
Competitive hourly pay: $51.34 to $60.41
Full-time, stable contract position
Comprehensive health benefits (medical, dental, vision)
Prescription and life insurance coverage
401(k) retirement plan eligibility
Short-term disability coverage
Equal opportunity and inclusive workplace environment
Company Description:
Randstad Life Sciences is a globally recognized leader in providing staffing solutions to the pharmaceutical, biotechnology, and healthcare industries. Their dedicated clinical research division connects skilled professionals with top-tier companies, fostering growth and innovation across the drug development sector.
Work Mode:
On-site – San Rafael, CA, USA
Call-to-Action:
Ready to elevate your clinical research career? Apply now to become a vital part of global study operations and contribute to impactful healthcare solutions.
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