TMF Document Specialist

Crinetics Pharmaceuticals • Headquarters, KY

2d • $69,000 - $86,000

About The Position

The TMF Document Specialist will participate in the execution of Phase 1-3 clinical trials. The TMF Document Specialist will handle, review and quality check clinical trial documents in the Trial Master File (TMF) by ensuring adherence to quality standards, (ALCOA ++), Good Documentation Practices (GDocP), regulatory requirements and Standard Operating Procedures (SOPs). The TMF Document Specialist will work across multiple Crinetics studies. Essential Job Functions and Responsibilities: These may include but are not limited to:

Requirements

• Veeva Vault eTMF experience
• Minimum of 2 years’ experience working in a clinical research (clinical operations) environment with direct “hands-on” TMF experience
• Knowledge of ICH/GCP guidelines, TMF Reference Model.
• Solid planning, organizational and time management skills, including the ability to support and prioritize multiple tasks / studies
• Knowledge of clinical trial documents that are maintained in the eTMF
• Knowledge of (ALCOA ++) and Good Documentation Practices (GDocP)
• Attention to detail

Responsibilities

• Performs TMF activities efficiently in compliance with ICH GCP requirements, SOPs, Work Instructions (WIs) local laws and regulations, TMF Management Plan and TMF Content Map
• Supports the maintenance of the TMF, perform TMF document process activities such as reviewing, approving, rejecting, and editing metadata as applicable
• Perform thorough (ALCOA ++) and Good Documentation Practices (GDocP) quality review of documents submitted for filing into the TMF and liaise with Document Owners to resolve any issues or queries identified
• Perform Certified copy process on clinical trial documents, as needed
• Perform redaction on sensitive clinical trial documents, as needed
• Completes routine administrative tasks in a timely manner
• Ensures internal and study-related training are completed per study timelines
• Ensures all study deliverables are completed per Crinetics and study timelines
• Other duties as assigned

Benefits

• discretionary annual target bonus
• stock options
• ESPP
• 401k match
• health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• winter company shutdown

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed