TMF Document Specialist

Position Summary:

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:

• 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

Education and Experience:

Required:

• 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

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:

You may be required to travel for up to 5% of your time.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

Salary Range

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.