Clinical Research Coordinator Sr.

Jefferson Health Plans • Philadelphia, NJ

1d

About The Position

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. 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. For more benefits information, please click here In keeping with Jefferson's Mission, We Improve Lives, it is our goal to recruit, retain, develop and reward highly-qualified employees. If you are enthusiastic, caring and dedicated to service excellence, we invite you to consider joining Jefferson. Jefferson encourages its employees to expand their knowledge and develop their careers through growth opportunities and continuing education. With a long standing history, Jefferson has been advancing the medical field from the heart of Center City Philadelphia for nearly 200 years. Our Mission, We Improve Lives, expands to every corner of the organization. From our weekly farmer’s market, to our new Jefferson Accelerator Zone for innovation, our employees’ passion for the community is evident by the daily gestures towards our patients, students and each other.

Requirements

• 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.

Responsibilities

• 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.
• 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.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED