Clinical Trial Associate
Hays

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

A Pharmaceutical Company is seeking a Clinical Trial Associate in South San Francisco, CA.

Role Description

• Sets up and maintains electronic Trial Master File (TMF) for multiple studies.
• Ensures that TMFs are always inspection-ready and assists with inspection preparation activities.
• Coordinates and/or conducts regular QC of TMFs and ensures findings are appropriately resolved.
• Acts as business administrator for eTMF and conducts user training.
• Reviews essential documents in support of site activation.
• Provides technical support to study teams by collating and organizing documents and data from multiple
sources.
• Accountable for study-level tracking (e.g., site activation, enrollment) as assigned by the team.
• Supports Study Management Teams by coordinating meetings, distributing agendas, and preparing clear,
organized, and accurate meeting minutes.
• May assist with financial activities (e.g., reviewing or reconciling invoices), as requested.
• Adheres to Good Clinical Practice and company Standard Operating Procedures.
• Participates in department initiatives and development of department procedures.

Skills & Requirements

• Bachelor's degree in a relevant scientific discipline
• 2+ years of relevant Clinical Operations experience
• Solid experience with Trial Master File maintenance, including TMF Reference Model, TMF set-up, and TMF
QC activities
• Hands-on experience with Veeva Vault TMF is highly desirable.
• Demonstrated ability to drive results that are needed to achieve company objectives in accord with company's
culture and values - courageous, imaginative, selfless and joyful.
• Demonstrated ability to manage multiple assignments; prioritizes work and problem-solves independently yet
understands when to involve others.
• Excellent interpersonal skills. Demonstrated ability to work as a team player.
• Strong communication skills, including active listening, verbal, and written communications skills.
• Strong attention to detail and excellent organization skills required.
• Proficient w/ Microsoft Office products (Excel, PowerPoint, Word).
• Understanding of Good Clinical Practice and application to assignments

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.

• Medical
• Dental
• Vision
• 401K
• Life Insurance ($20,000 benefit)

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is an Equal Opportunity Employer including disability/veteran.

In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570

Drug testing may be required; please contact a recruiter for more information.
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