Clinical Trial Associate (Temporary) - United States
BioMarin’s Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The Clinical Trial Associate position is a key support role within Clinical Operations, undertaking essential coordination activities for the study team.
Assist with study coordination activities, including:
Conduct study tracking support (e.g., CTMS tracking, start-up tracking, milestone tracking, close-out tracking) and study updates
File, track and maintain TMF
Maintain internal/external contact list
Conduct electronic documentation and records management
Perform document tracking and signature/approval follow-up, where applicable, including Confidential Disclosure Agreements (CDAs), contracts, proposals, payments, invoices, and other study documentation
Execute meeting logistics (e.g., meeting minutes, expense reports, and travel coordination)
Ensure timely study entry and updates to ClinicalTrials.gov
Prepare investigator meeting materials
Design and prepare study related materials for the training of internal and external staff
Assist with study conduct activities, including:
Facilitate CDA and contract execution. Assist with regulatory package review
Request and distribute insurance certificates for sites – as delegated by, and under the oversight of, Study CRA or Study Lead
Contact and identification of investigators for participation in clinical studies
Enrollment and Maintenance:
Issues identification, resolution, and escalation
Track site payments and vendor invoices
Conduct study closure activities (sites, reconciliation activities, filing & archiving)
Track, collate clinical trial documentation related to CSR appendices
2-5 years of clinical research experience, preferrably within biotech or pharm industry.
Bachelor’s Degree desired and/or equivalent experience in Life Sciences, Nursing, or related disciplines
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.