Job Details
Works independently or with minimal supervision to oversee the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Runs portions of 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. May also assist with the orientation and training of new staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups.
Job Description
Essential Functions:
- Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
- 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 expense, 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.
This position is a regulatory-only role, focused on clinical trial regulatory responsibilities and not patient-facing
Minimum Education and Experience Requirements:
Education:
Minimum High School Diploma or equivalent.
AND
Experience:
High School Diploma or equivalent and SoCRA certification preferred and 6 years of clinical research experience or bachelor’s degree and 2 years of clinical research experience or master’s degree and 1-year clinical research experience.
Work Shift
Workday Day (United States of America)
Worker Sub Type
Regular
Employee Entity
Thomas Jefferson University
Primary Location Address
833 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
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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