Clinical Research Lead

Clinical Trial Manager

Works independently. Conducts clinical trials from startup to closeout, including protocol coordination (screening, recruiting, enrolling, consenting), feasibility planning, data management, biological specimen management, preparation for monitoring visits, and regulatory and / or IRB document preparation. Ensuring all study procedures are conducted according to the protocol and applicable regulations. Trains research staff, supervises staff and oversees clinical trials from start-up to closeout. Develops and / or contributes to standard operating procedures and processes. Attends and engages in leadership meetings, represents Thomas Jefferson University 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 a clinical trial in accordance with Good Clinical Research Practice (GCP).

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

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

Maintains accurate subject log, tracks expenses, submits appropriate documentation to Grant Administrator on a monthly basis for payment due for visits on all studies.

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

Organizes and maintains documentation of all patient 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 years of clinical research experience.

Work Shift : Workday Day (United States of America)

Worker Sub Type : Regular

Employee Entity : Thomas Jefferson University

Primary Location Address : 1025 Walnut Street, Philadelphia, Pennsylvania, United States of America

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.

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.

Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.

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