Clinical Research Project Manager

Thomas Jefferson University & Jefferson Health; Philadelphia (Philadelphia County); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading healthcare institution is seeking a Clinical Research Project Manager to oversee clinical trials from initiation to completion. The role involves training staff, ensuring compliance with regulations, and managing data. Candidates should possess a Bachelor's or Master's degree in a relevant field with significant clinical research experience.

Qualifications

• Bachelor's degree with 5 years of clinical research experience or Master's Degree with 3 years of clinical research experience.
• Experience in Good Clinical Practice (GCP) required.

Responsibilities

• Conducts clinical trials from startup to closeout.
• Trains and supervises research staff.
• Prepares and submits materials for the Institutional Review Board (IRB).
• Maintains accurate subject logs and tracks expenses.

Skills

Clinical trial management

Data management

Regulatory compliance

Staff training

Education

Bachelor's degree

Master's degree

Job description

Job Details

Clinical Research Project Manager

Job Description

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. Ensures 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 operations in a division or department, and provides expert consulting at an institutional level.

• Oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP).
• Trains and supervises research staff on 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 logs, tracks expenses, and submits appropriate documentation to Grant Administrator monthly for payment processing.
• Performs regular quality control assessments to ensure clinical trial data is collected and stored per GCP.
• Organizes and maintains documentation of all patient data.
• Designs electronic capture databases, if appropriate, and manages all collected data.
• May provide clerical and technical support to ensure adherence to research protocols and data quality.

Education:

Bachelor's degree with 5 years of clinical research experience or Master's Degree with 3 years of clinical research experience.

Work Shift

Workday Day (United States of America)

Worker Sub Type

Regular

Primary Location Address

1015 Chestnut Street, Philadelphia, Pennsylvania, United States of America

Jefferson, located in the greater Philadelphia region, Lehigh Valley, Northeastern Pennsylvania, and southern New Jersey, is reimagining health care and higher education to create unparalleled value. With over 65,000 staff, Jefferson provides high-quality clinical care, advances research, and educates future professionals across its 10 colleges and three schools, serving more than 8,300 students. Jefferson Health, ranked among the top 15 non-profit health systems nationally, operates 32 hospital campuses and over 700 outpatient locations. Jefferson Health Plans offers broad health coverage options in Pennsylvania and New Jersey for over 35 years.

Jefferson is committed to equal opportunity employment and education, regardless of age, race, color, religion, creed, sexual orientation, gender identity, marital status, pregnancy, national origin, citizenship, military or veteran status, disability, or any other protected status.