Document processor Jobs in Sacramento, CA

A client of Innova Solutions is immediately hiring for a TMF Operations Specialist.

Position type: Full-time– Contract
Duration: 4 Months
Location: Novato California 94949 (HYBRID)

As TMF Operations Specialist, you will:

Job Description: This position is responsible for the maintenance, quality review, transfer, closure and archival of Sponsor Trial Master File (TMF) essential documentation in accordance with regulatory requirements and principles and standards of Good Clinical Practice (GCP) International Conference on Harmonization Regulations (ICH) E6 (R3), and European Union (EU) regulations/directives, and Client Standard Operating Procedures (SOPs) as appropriate. The TMF Operations Specialist will provide support to the TMF content owners on one or more clinical programs. This position serves as a pivotal point of contact and works closely with internal Study Management Teams (SMTs) and external CROs/Vendors to ensure that the TMF is complete, accurate, contemporaneous, and inspection ready according to Client TMF SOPs and TMF Plans. The core duties and responsibilities of the Clinical Document Specialist include, but are not limited to:

Responsibilities:

• Perform quality checks of TMF document submissions (uploads) for approval, identify and assign any quality issues (QIs), and follow-up for action completion and QI resolution
• Ensure TMF documentation follows the requirements outlined in study-specific TMF Plans and Indices including but not limited to document classification, expectedness, filing level, naming conventions, metadata assignment, responsibility, filing locations, etc.
• Track periodic and final review intervals and provide TMF full report/inventories for study team review performance; verify review completion and quality issue (QI) resolution and issue TMF periodic and final review completion certificate(s)
• Support TMF final transfer activities for the receipt, review, acceptance, and archival of TMF transfers from external CROs/Vendors
• Attend TMF Operations and SMT meetings regularly and provide updates on SMT TMF performance, status updates, trends in identified quality issues, risk mitigations, and outstanding/open quality issues
• Work cross-functionally with internal departments and external resources (e.g., CROs, Partners, etc.) to resolve gaps for a study TMF

Requirements:

• This position is remote based, but candidates must reside within the Novato, CA area for ad-hoc on-site visits to the Novato, CA office for receipt, inventory review, and storage of TMF Final Transfers.
• Bachelor’s degree or equivalent curriculum (scientific or healthcare discipline preferred) and a minimum of 2 years of professional TMF document control experience.
• Experience with electronic trial master file systems (Veeva Vault eTMF), workflows, configurations, feature/functionality, and industry best practices for business process alignment
• Advanced knowledge of ICH/GCP Regulations, GDP and ALCOA+ requirements, CDISC Reference Model, and industry best practices
• Demonstrated knowledge of Sponsor TMF regulatory requirements and an understanding of the range of working procedures relating to it, together with an understanding of Good Documentation Practices (GDP)
• Familiarity with international clinical trials, clinical trial documents, and document QC process highly desirable
• Works under general supervision and guidance. Works with Manager to establish priorities and timelines
• Strong computer skills (MS Office) including exposure to data/document management systems.

Thank you!
Lailun Sheikh
Phone:


PAY RANGE AND BENEFITS:
Pay Range*: $30.00 - $40.00 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).