Clinical Research Lead

Job Details

Clinical Research Lead

Job Description

CR Lead Startup - Works independently. Conducts clinical trials from startup to feasibility planning, data management, preparation for sponsor visits, and regulatory and/or IRB document preparation.  Ensuring all study startup procedures are conducted according to applicable regulations.  Trains research staff, supervises staff and oversees clinical trials start-up through activation. Develops and/or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents TJU internally and externally, oversees research operation in a division or department and provides expert consulting at an institutional level.

• Oversees the day-to-day activities of clinical trial startup and activation in accordance with Good Clinical Research Practice (GCP) and Jefferson study activation timelines.

• Trains research staff on the proper procedures for conducting a clinical trial per GCP.

• Prepares and submits all materials for internal committee reviews, including the Institutional Review Board (IRB) and other regulatory bodies as required by the protocol and CCSG to ensure compliance in a timely fashion.

• Maintains accurate new protocol log, tracks budgets and contracts, submits appropriate documentation to Grant Administrator on a routine basis for all studies in development.

• Performs regular quality control assessments to ensure that clinical trial startup data is collected and stored per GCP and CCSG guidelines.

• Organizes and maintains documentation of all startup data.

• Designs electronic capture databases, if appropriate, and manage all the data collected.

• May provide clerical and technical support to ensure adherence to research protocols and quality of information received.

Education:

Bachelor’s degree and 5 years of clinical research experience or Master’s Degree and 3 year clinical research experience.

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. 

Benefits

At Jefferson, we offer a comprehensive total rewards package designed to support the health and well-being of our colleagues and their families. It includes a wide range of benefits including competitive pay, health and retirement benefits, life and disability insurance, paid time off, educational benefits, financial and mental health resources and much more. Our diverse benefits offerings ensure you have the coverage and access to services you need to thrive both personally and professionally.