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Dept- Tisch 015 REQ # 2564968
Job Title: Associate Director, Quality Assurance & Regulatory Compliance, Clinical Research
- The Tisch Cancer Institute (TCI) at the Mount Sinai Health System oversees approximately 250 active clinical trials with over 500 research participants across 4 locations in the NYC with a large catchment area of 10,000+ patients. With the recent integration of cancer research operations across the Health System, TCI has an opportunity to become one of the largest Clinical Research Program in the country and the need to be efficient and compliant is critical.
- The Associate Director is directly responsible for the TCI’s Quality Assurance Program and the strategic implementation and management of a Centralized Regulatory Compliance Services across Health System’s Cancer CTOs. He/She is also responsible for developing and implementing centralized standards for research operations and processes (SOPs) across sites (e.g. Mount Sinai, Beth Israel, St. Luke’s Roosevelt, NYEEI); assuring compliance of these policies (SOPs); and developing a System Wide Research training and education program.
- Reporting directly into the Executive Director of Clinical Research Operations, the candidate will manage the day to day operations of the following programs across the Health System Oncology Services with up to 15 FTEs:
- Work collaboratively with CCTO’s Executive Director of Clinical Operations and Disease Research Team Managers (e.g. MPD, MDS, Myeloma, BMT) and the leadership in the patient clinics (e.g. Ruttenberg; Dubin; BI PAC, West, Roosevelt etc) to assure quality control and protocol compliance.
- Perform Internal GCP & data integrity Audits and CAPs
- Create, implement and validate CCTO SOPs
- Assure SOPs are followed and implement correct action plans when necessary
- Training of Investigators
- Training of Research Personnel
- Oversee & audit Subject Central Registration
- Perform and maintain a Training and Education program for CRCs, CRNs and other research personnel
- Provide Administrative oversight and support to the TCI DSMC
- Collaborated with Institutional Compliance Offices, including IRB, RDC, Bio-safety, Research Compliance, etc.
- Report results to TCI Clinical and Population Research Committee
- Centralized Regulatory Coordination and Compliance Services
- Oversee disease research specific regulatory staff responsible for IRB submissions and sub-committees related to human subjects research
- Oversee regulatory staff responsible for NCI cooperative group relations (e.g. ALLIANCE, NRG, COG, etc.)
- Work with TCI Translational Research Core facilities (e.g. vaccine core; biostatistics)
- Collaborate with the Dean’s Office of Research Services (e.g. IND/IDEs, clinicaltrials.gov; monitoring) to eliminate duplication of services
- Produce metrics reports in collaboration with the data management & reporting team
- Implement progress improvement to decrease time to study activation
- Assist the PRMS administration with implementing PRMC submissions including pre-PRMS review processes (DFGs, RAE and DSMCs) across the Health System
- Centralized Pre-Award Financial Coordination
- Oversee financial manager and coordinators
- Liaison with sponsors (Industrial) and/or BRANY when necessary
- Oversee CCTO’s Resource Allocation Evaluation
- Assist with clinical trials budget negotiations & centralization of research charge master/fee schedule
- Collaborating with ancillary oncology service lines; and other institutional research administrative offices e.g. MSIP, IDS, FACTS, GCO, BRANY, for CDA, MCA, CTAs, etc.
- Assure standardization of EMR for research and billing compliance initiatives via EPIC/BEACON with Hospital Finance
- Daily interactions with TCI’s Finance Director and post-award Finance Coordinators to assure accurate representation of CCTO staff time/effort and help develop opportunities to prevent clinical trials deficits
- Other special projects as necessary including presentations to leadership, chairing and/or co-chairing relevant meetings, participate in hospital and research IT committees related to QA and compliance, produce various metrics report to improve operations, retreats, etc.
- Candidate is expected to spend 20-50% of the time at BI; Roosevelt; NYEEI and/or St. Luke’s to assist with implementing processes with CCTO’s Executive Director.
- Bachelor’s Degree (in a Science related discipline preferred); Master’s Degree preferred
- Minimum Related Experience
- 5 years of clinical trials management/leadership experience with Quality Assurance experience in phase I to phase IV clinical trials.
- Skills & Abilities:
- MS Office Applications (including Microsoft Word , PowerPoint, Excel, and Outlook)
- Electronic Data Capture experience necessary (i.e. CTMS)
- Experience with electronic medical record systems/EMR; EPIC plus
- Excellent written, oral presentation and interpersonal skills
- Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance
- Proven ability to provide scientific and clinical expertise in all phases of clinical trials
- Excellent analytical and problem solving skills Independent thinking and planning ability; Knowledge of and experience with GCP and GLP
- Good teamwork skills, as well as the ability to work independently