Clinical Research Lead

Jefferson Health; Philadelphia (Philadelphia County); On-site; USD 120,000 - 170,000; Full time

Job summary

Jefferson Health in Philadelphia seeks a Clinical Research Lead to independently manage clinical trials from startup to closeout. You will coordinate protocols, screening, consent, data management, and regulatory submissions, ensuring adherence to GCP and study plans.

You will train staff, oversee trial operations, and contribute to SOP development while representing TJU internally and externally. You will oversee day-to-day trial activities, prepare IRB submissions, monitor budgets, and ensure

Qualifications

• Bachelor’s degree required with clinical research experience; advanced degree preferred.
• CCRA certification or equivalent required.
• Experience leading trials from startup to closeout and coordinating with IRB and regulatory bodies.

Responsibilities

• Oversees day-to-day activities of a clinical trial per GCP.
• Trains and supervises research staff in proper trial procedures.
• Prepares and submits materials for IRB and regulatory bodies.
• Maintains subject logs and tracks study expenses for grant administration.
• Performs quality control on trial data and documentation.
• Designs or manages electronic data capture databases for studies.

Skills

Clinical trial oversight

GCP compliance

Staff training

Regulatory submissions

IRB coordination

Data management

Education

Bachelor’s degree in a relevant field

Master’s degree in a related field

CCRA certification

Tools

EDC systems

Job description

Clinical Research LeadSkip to main content#Clinical Research Lead page is loaded## Clinical Research LeadApplylocations: Philadelphia, PAtime type: Full timeposted on: Posted Todayjob requisition id: REQ-0034545**Job Details**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 TJU internally and externally, oversees research operation in a division or department and provides expert consulting at an institutional level.**Job Description** **Summary** 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 TJU internally and externally, oversees research operation in a division or department and provides expert consulting at an institutional level. **Job Duties*** Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.(Do not delete, move or over-write this statement)* 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. **Minimum Qualifications*** High School Diploma/GED Minimum High School Diploma or equivalent* 5 years Bachelor’s degree and 5 years of clinical research experience* 3 years Master’s Degree and 3 year clinical research experience.* CCRA - Certified Clinical Research Associate - Association of Clinical Research Professionals **Physical Demands** Lift and carry 25 lbs. frequent sitting/standing, frequent keyboard use, \*patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR. Job Description Disclaimer: This position description provides the major duties/responsibilities, requirements and working conditions for the position. It is intended to be an accurate reflection of the current position, however management reserves the right to revise or change as necessary to meet organizational needs. Other responsibilities may be assigned when circumstances require.**Work Shift**Workday Day (United States of America)**Worker Sub Type**Regular**Employee Entity**Thomas Jefferson University**Primary Location Address**1015 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.For more benefits information, please click here