111152 - Trial Master File (TMF/eTMF) Specialist
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#111152 Trial Master File (TMF/eTMF) SpecialistInitial Review Date: Tue 10/12/2021
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UCSD Layoff from Career Appointment: Apply by 08/16/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 08/26/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will remain open until a candidate has been successfully identified.
The Alzheimer's Disease Cooperative Study (ADCS) is a growing, progressive, multi-center clinical trials consortium created to provide an operational framework for large scale Alzheimer’s disease research projects and was formed in 1991 as a cooperative agreement between the National Institute on Aging (NIA) and the University of California, San Diego. The ADCS consists of 7 cores, 22 committees, ~40 research sites that are members of the consortium/Steering Committee, and an additional 30 or more research sites located across the U.S. and Canada that participate in one or more trials coordinated by the ADCS. Annual funding for the ADCS ranges from $10-$25M. The ADCS provides expertise in developing Alzheimer's disease related protocols and is the coordinating center for multiple clinical trials of varying sizes and complexity under subcontracts funded by NIH, the Alzheimer's Association, and clinical trial agreements with industry partners.
The Trial Master File (TMF) Specialist will report to the QA/Regulatory Manager, and is responsible for managing the life-cycle of TMF activities for all ongoing and new ADCS clinical trials. Responsibilities also include TMF process development and implementation in accordance to regulatory requirements, ADCS internal SOPs and the study-specific TMF plans, as well as supporting the ADCS clinical project teams to ensure TMF quality, per ICH E6 (R2) guidelines for regulatory inspection readiness. The ADCS TMF Specialist will be responsible for the set-up, maintenance, monitoring completeness, quality control metrics and TMF closeout activities.
In addition to being responsible for the set up and indexing (standardizing file structures and nomenclature), the (e)TMF Specialist is also responsible for training and on-boarding study contributors into the specific TMF or eTMF for the ADCS projects, filing study documents onto the TMF in accordance to the index, managing the life-cycle TMF activities from initiation to close-out; communicating and collaborating with ADCS internal and external teams (sponsors or TMF vendor(s)) to ensure completeness and quality of filed clinical trial documents; working cross-functionally to resolve TMF-related issues; providing regular status reporting on the TMF quality, completeness, and audit readiness while identifying and mitigating GDP potential risks; assisting in periodic internal ADCS as well as external TMF audits, as directed by the Clinical Project Lead or designee; and supporting the clinical research project teams preparing the TMF records for transfer, long-term on-site or off-site archival.
Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies/procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participant at undo risk and/or compromise the institution's assurance of regulatory compliance with the federal government.
Bachelor's degree in related area; and/or equivalent experience/training.
At least three (3) years of TMF experience required, including experience in study start-up, maintenance and closeout activities. Subject matter expertise with the TMF Reference Model, clinical trial activities and related terminology.
Demonstrated experience with CTMS, EDC, and eTMF technologies.
Extensive knowledge and application of ALCOA FDA standards, Good Clinical Practice, and Good Documentation Practice, per ICH (E6 (R2).
Experience in clinical trials related roles (i.e. clinical operations and project management) or managing a clinical trial project. Has an understanding of clinical study phases involved in Drug Development and the corresponding records requirements, in accordance to federal regulations.
Highly proficient at using current CTMS and eTMF technologies. Knowledge and skills in navigating EDCs preferred.
Demonstrated understanding of the clinical study phases involved in Drug Development and the corresponding records requirements, in accordance to federal regulations.
Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents.
Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.
Proficiency in public speaking, and writing. Strong communication and interpersonal skills and ability to work effectively with cross-functional teams.
Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.
- Employment is subject to a criminal background check.
- Must be willing to work outside of normal business hours, including evenings and weekends to meet clinical trial timelines and deadlines.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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