Clinical Research Coord Senior - Integrated Medicine

Thomas Jefferson University & Jefferson Health; Lansdale, Buffalo (Montgomery County, NY); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a dedicated Clinical Trial Coordinator to manage daily activities of clinical trials. This role involves overseeing compliance with Good Clinical Practice (GCP), training research staff, and ensuring accurate data management. You will engage in protocol coordination, regulatory submissions, and quality control assessments to maintain data integrity. Join a forward-thinking organization committed to advancing healthcare and education, where your contributions will significantly impact clinical research and patient care.

Qualifications

• 6 years of clinical research experience or relevant degrees with experience.
• SoCRA certification preferred.

Responsibilities

• Oversee daily activities of clinical trials in compliance with GCP.
• Prepare and submit materials for IRB and regulatory bodies.
• Train and supervise research staff on clinical trial procedures.

Skills

Clinical Research

Good Clinical Practice (GCP)

Data Management

Regulatory Compliance

Training and Supervision

Education

High School Diploma

Bachelor's Degree

Master's Degree

Tools

Electronic Data Capture Systems

Job description

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). Responsibilities include running 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 IRB document preparation. Ensures all study procedures are conducted according to the protocol and applicable regulations. May assist with the orientation and training of new staff and participate in developing workflows, training documents, and SOP revisions. Engages in work groups as needed.

Job Description

Essential Functions

• Interacts professionally with co-workers, visitors, and other staff, reflecting the values of Jefferson.
• Oversees daily activities of clinical trials in compliance with GCP.
• Trains and supervises research staff on proper clinical trial procedures per GCP.
• Prepares and submits materials for IRB and other regulatory bodies to ensure compliance and timely approval.
• Maintains accurate subject logs, tracks expenses, and submits documentation to the Grant Administrator monthly for study-related payments.
• Performs quality control assessments to ensure data integrity and adherence to GCP.
• Organizes and maintains comprehensive documentation of patient data.
• Designs electronic data capture databases when appropriate and manages collected data.
• Provides clerical and technical support to ensure protocol adherence and data quality.

Minimum Education and Experience Requirements:

Education: Minimum High School Diploma or equivalent.

Experience: High School Diploma or equivalent with SoCRA certification (preferred) and 6 years of clinical research experience, or a bachelor's degree with 2 years of experience, or a master's degree with 1 year of experience.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Primary Location Address

789 East Lancaster Avenue, Villanova, Pennsylvania, United States of America

Jefferson, located in the greater Philadelphia region, Lehigh Valley, Northeastern Pennsylvania, and southern New Jersey, is dedicated to reimagining healthcare and higher education. With over 65,000 staff, Jefferson provides high-quality clinical care, conducts cutting-edge research, and educates future professionals through its 10 colleges and three schools. Jefferson Health is a top-ranked, not-for-profit healthcare system serving millions annually across numerous hospitals and outpatient facilities. Jefferson Health Plans offers broad health coverage options in Pennsylvania and New Jersey.

Jefferson is committed to equal opportunity employment and educational practices, welcoming applicants regardless of age, race, color, religion, sexual orientation, gender identity, marital status, pregnancy, national origin, military or veteran status, disability, or other protected status.