Job Details
The Protocol Review and Monitoring Committee (PRMC) Coordinator is a central operational and administrative leader responsible for ensuring the efficient oversight of clinical research protocols. This role manages the full lifecycle of protocol review and monitoring activities, serving as a key liaison among investigators, study teams, scientific reviewers, and institutional stakeholders. Responsibilities include coordinating the intake, triage, and processing of protocol submissions; facilitating the review process by assigning reviewers, tracking progress, and ensuring adherence to timelines; and executing expedited and administrative approvals in accordance with established guidelines. The Coordinator organizes and supports committee and subcommittee meetings, prepares agendas and materials, documents reviewer feedback, and ensures timely communication of decisions. They also monitor ongoing studies for compliance with annual review requirements and accrual expectations, maintaining communication with study teams to ensure timely follow-up and resolution of issues. Additionally, the role involves maintaining accurate committee records, including membership and participation metrics, and developing and delivering training for both study teams and new committee members on policies, procedures, and submission systems.
Job Description
SummaryThe Protocol Review and Monitoring Committee (PRMC) Coordinator is a central operational and administrative leader responsible for ensuring the efficient oversight of clinical research protocols. This role manages the full lifecycle of protocol review and monitoring activities, serving as a key liaison among investigators, study teams, scientific reviewers, and institutional stakeholders. Responsibilities include coordinating the intake, triage, and processing of protocol submissions; facilitating the review process by assigning reviewers, tracking progress, and ensuring adherence to timelines; and executing expedited and administrative approvals in accordance with established guidelines. The Coordinator organizes and supports committee and subcommittee meetings, prepares agendas and materials, documents reviewer feedback, and ensures timely communication of decisions. They also monitor ongoing studies for compliance with annual review requirements and accrual expectations, maintaining communication with study teams to ensure timely follow-up and resolution of issues. Additionally, the role involves maintaining accurate committee records, including membership and participation metrics, and developing and delivering training for both study teams and new committee members on policies, procedures, and submission systems.
Job Duties- Receives, triages, and manages protocol submissions through the submission platform, serving as the primary liaison between study teams, principal investigators, and the PRMC, while supporting the review process by assigning reviewers, tracking progress, and ensuring deadlines are met.
- Executes decisions regarding expedited approval and studies requiring administrative approval, manages all PRMC correspondence including email communications related to protocol approvals, amendments, and stipulations.
- Coordinates all full committee, sub-committee, and scientific committee activities, including scheduling meetings, preparing agendas and meeting materials, documenting reviewer comments, distributing decision emails, and recording minutes.
- Monitors trials for PRMC annual review deadlines and minimum accrual expectations, manages related communications with study teams to ensure compliance and timely follow-up, and maintains membership records including rosters, attendance logs, and participation metrics.
- Develops and delivers training and education for study teams regarding PRMC policies and submission requirements, and trains all new PRMC members on review processes and use of the submission management platform.
Minimum Qualifications- High School Diploma/GED 6 years clinical research experience or
- Bachelor’s Degree 2 years clinical research experince or
- Master’s Degree 1 year clinical research experience
- 5 years 6 years HS Diploma relevant clinical research experience or
- 2 years Bachelor's degree relevant clinical research experience or
- 1 year Master's degree relevant clinical research experience
- Familiarity with medical terminology
- Exceptional organizational, time-management, and multitasking skills with attention to detail, accuracy, and proven ability to meet deadlines.
- Detail-oriented with a high level of accuracy in managing data and documentation.
- Excellent written and verbal communication skills, with the ability to communicate scientific content clearly to diverse audiences.
- Strong interpersonal skills and the ability to work effectively with scientists, researchers, and administrative staff.
- Proficiency using various software platforms including Microsoft Office 365 Suite, virtual meeting platforms (e.g. Zoom, Microsoft Teams);
- Experience coordinating meetings, preparing agendas, and maintaining accurate records, including documentation and attendance tracking.
- Understanding of regulatory processes and ability to handle sensitive information with discretion.
- Adaptability, initiative, and problem-solving skills in a dynamic, fast-paced environment.
Additional Qualifications- Employees must reside within a two-hour driving radius of Thomas Jefferson University and maintain a dedicated, professional home workspace with reliable internet access.
Physical DemandsLift 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
Albert Einstein Medical Center
Primary Location Address
5501 Old York Road, 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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