Job Details
Responsible for the coordination and oversight of clinical research trials from start-up through close-out. Ensures that clinical trials are conducted in compliance with approved protocols, regulatory requirements and sponsor expectations.Job Description
Study Management
- Lead daily clinical research operations and ensure activities follow approved study protocols.
- Oversee participant recruitment, screening, informed consent, and enrollment.
- Schedule and coordinate study visits, procedures, and sample collection.
- Manage and maintain accurate study documentation and regulatory files.
- Collect, process, code, and analyze clinical data; prepare reports for sponsors and investigators.
Regulatory & Compliance
- Ensure compliance with Institutional Review Boards (IRB), FDA, and other regulations governing human subject research.
- Prepare and submit regulatory documents, amendments, and safety reports.
- Participate in internal and external audits, quality assurance, and monitoring visits.
Protocol Development & Research Support
- Contribute to new protocol development and implementation planning.
- Support preparation of research manuscripts, reports, and grant proposals
- Communicate with investigators, clinical staff, sponsors, and external partners.
High School Diploma or equivalent and SoCRA certification 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
RegularEmployee Entity
Thomas Jefferson UniversityPrimary Location Address
925 Chestnut Street, Philadelphia, Pennsylvania, United States of AmericaNationally 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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