PRIMARY FUNCTION:

Incumbent will be responsible for ensuring that clinical trials in the Jefferson regional Advanced Care Hubs (ACH) are conducted in accordance with Federal, and State governance, institutional regulations, GCP/ICH, and follow all applicable policy. This position will have oversight of regional clinical research program development to include feasibility, site resource and capability assessments, and all site specific study conduct within the ACHs from protocol inception to completion of all required protocol visits and follow-up, in collaboration with the disease management teams. All clinical trial requirements including but not limited to regulatory aspects, clinical coordination, data integrity and management, clinical trial billing and billing compliance, clinical staff (clinical coordination, research nurses) and data management training of and competence of clinical research staff in the ACHs will fall under the auspices of the Associate Director. The Associate Director will also oversee other community research outreach functions of the Clinical Trials Office to include Screening and Recruitment Services, engagement with Sidney Kimmel Cancer Network (SKCN) partners and affiliates, and Population Science Support Services. The Associate Director will be responsible for all non-clinical personnel and work closely with Nursing Leadership at each of the ACH locations. The Associate Director will work in conjunction with the physician leader of community clinical research.

EDUCATIONAL/TRAINING REQUIREMENTS:

Bachelor’s degree required. Master’s degree preferred

EXPERIENCE REQUIREMENTS:

At least 8 years of experience in clinical trials management. Minimum 5 years of experience managing/supervising direct reports

ADDITIONAL INFORMATION:

Knowledge of oncology cooperative groups’ (ECOG-ACRIN,NRG , etc.) regulatory process.

Knowledge of Code of Federal Regulations, good clinical practices (GCPs), and ICH Guidelines for the conduct of clinical trials to include all aspects of clinical and regulatory documentation

Experience with grant writing, report writing required

Excellent computer database skills; excellent scientific/medical writing skills; excellent project management skills, and excellent oral and written communication skills.

Jefferson includes Thomas Jefferson University and Jefferson Health, a dynamic university and health system with broad reach across the Delaware Valley. Jefferson is the second largest employer in Philadelphia and the largest health system in Philadelphia based on total licensed beds.

Through the merger of Thomas Jefferson University and Philadelphia University in 2017, our University includes ten colleges and four schools. We are an NCAA Division II university and an R2 national doctoral university offering undergraduate and graduate-level programs that provide students with a forward-thinking education in architecture, business, design, engineering, fashion and textiles, health, medicine and social science.

Jefferson Health, the clinical arm of Thomas Jefferson University, has grown from a three-hospital academic health center in 2015, to an 18-hospital health system through mergers and combinations that include hospitals at Abington Health, Aria Health, Kennedy Health, Magee Rehabilitation and Einstein Healthcare Network. We have over 50 outpatient and urgent care centers; ten Magnet®-designated hospitals (recognized by the ANCC for nursing excellence); the NCI-designated Sidney Kimmel Cancer Center (one of only 70 in the country and one of only two in the region); and one of the largest faculty-based telehealth networks in the country. In 2021, Jefferson Health became the sole owner of HealthPartners Plan, a not-for-profit health maintenance organization in Southeastern Pennsylvania. We are the first health system regionally to create an aligned payer-provider partnership.

Jefferson’s mission, vision and values create an organization that attracts the best and the brightest students, faculty, staff, and healthcare professionals, as well as the most visionary leaders to drive exceptional results.

• OUR MISSION: We improve lives.
• OUR VISION: Reimagining health, education and discovery to create unparalleled value
• OUR VALUES: Put People First, Be Bold & Think Differently and Do the Right Thing

As an employer, Jefferson maintains a commitment to provide equal access to employment. Jefferson values diversity and encourages applications from women, members of minority groups, LGBTQ individuals, disabled individuals, and veterans.