The Clinical Research Coordinator IV trains research staff, supervises staff and oversees clinical trials from start-up to close-out. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents TJU internally and externally, and oversees research operation in department, and provides expert consulting at an institutional level.
- Manages all Investigator-lead multi-site trials by developing and implementing processes for document management and IRB submission tracking (i.e. continuing reviews and amendments) for multi-center trials as well as have protocol status knowledge.
- Directs the preparation and submission of regulatory agency applications, reports, and correspondence for opening new studies, protocol amendments, informed consents, continuing reviews, FDA safety reporting, Investigational New Drug applications (INDs), annual reports, Investigational Device Exemption applications (IDEs), etc.
- Provides direct supervision of the research staff which includes conducting on-going training, reviewing workloads, completing annual evaluations, etc.
- Oversees documentation efforts to ensure compliance with domestic and international regulations and standards.
- Identifies issues, recommends changes, writes new standard operating procedures (SOPs) or update existing SOPs with the goal of enhancing regulatory compliance.
- Oversees the completion of all necessary regulatory preparations prior to sponsor visits (e.g., monitoring and auditing visits, site activation visits). Ensures that any regulatory action items resulting from a sponsor visit are completed in a timely and efficient manner.
- Ensures that regulatory document version control is maintained, and that all clinical trial documentation is "audit ready" at all times.
- Reviews all regulatory submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Creates and establishes a process for ensuring quality submissions to the TJU IRB and the FDA.
- Interacts with Principal Investigators (PIs), Jefferson Clinical Research Institute (JCRI), Office of Research Administration (ORA), Office of Human Research (OHR), hospital staff, etc. to ensure efficient processing of trials.
- Works with the Team to ensure all communications regarding regulatory documentation that are provided by sponsors are distributed and received by the regulatory staff in a timely manner.
- Actively participates and represents the departments in feasibility assessments.
- Manages all aspects of clinical research regulation from protocol inception to completion; and tracking quality metrics
- Directs regulatory documentation and workflow for clinical trials through the use of project management techniques and tools (e.g., spreadsheets, progress reports, priority setting).
- Maintains an efficient organizational structure for processing all clinical protocols assigned to the Team, which includes NCI cooperative group protocols, industry-sponsored trials, and investigator-initiated studies including multi-sites.
- Performs other duties as assigned.
Qualifications Education:
Bachelor's Degree Required
AND Experience:
Bachelors Degree and 5 years of clinical research experience or Master's Degree and 3 year clinical research experience. 2+ years of lead/Project Management experience.
Closing Statement 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.
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