Clinical Research Manager

Job Details

Clinical Research Manager

Job Description

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.
  
  

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.

Additional Information

• 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.
  
  

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Primary Location Address

1015 Chestnut Street, Philadelphia, Pennsylvania, United States of America

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200 undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.

Jefferson is committed to providing equal educa­tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status.