Clinical Research Project Manager

Thomas Jefferson University; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision

Life and disability coverage

Retirement plans

Tuition assistance

Voluntary benefits

Job summary

Thomas Jefferson University is seeking a Clinical Research Project Manager to lead trials from start-up through closeout, ensuring adherence to protocol, GCP, and regulatory standards. You will oversee feasibility, recruitment, data and specimen management, and regulatory submissions, while driving process improvements and mentoring staff.

The role represents TJU in internal and external forums and provides expert guidance on clinical research processes, compliance, and multi-site trial

Qualifications

• Bachelor’s degree required; Master’s preferred.
• Minimum 5 years of clinical research experience with 3 years in leadership or project management.
• Strong knowledge of regulatory requirements and GCP.

Responsibilities

• Lead and manage clinical trials from start-up to closeout, ensuring compliance with GCP and applicable regulations.
• Coordinate feasibility assessments, protocol activities (screening, recruiting, enrolling, consenting), data and biological specimen management, and monitoring preparation.
• Supervise, train, and mentor research staff; ensure proper conduct, protocol adherence, and consistent application of regulatory and institutional standards.
• Prepare, review, and submit regulatory and IRB documentation; maintain accurate study records and subject logs.
• Track study finances, perform quality control to ensure data integrity, audit readiness, and regulatory compliance.
• Develop and implement standard operating procedures; participate in leadership initiatives; provide expert consultation on clinical research processes and compliance.
• Represent the organization internally and externally and liaise with stakeholders to support efficient trial processing.

Skills

Project management

Regulatory compliance

GCP knowledge

Leadership

Communication

Education

Bachelor’s Degree

Master’s Degree (preferred)

Job description

Overview

The Clinical Research Project Manager independently leads and manages clinical trials from study start-up through closeout, ensuring adherence to protocol requirements, institutional standards, and applicable regulatory guidelines. This role provides operational oversight of research activities, including feasibility planning, subject recruitment and retention, data and specimen management, and regulatory compliance. The manager may supervise and develop research staff, drives process improvements, and contributes to the development of standard operating procedures. The position represents the organization in internal and external forums and serves as a subject matter expert, providing strategic guidance and consultation at the departmental or institutional level.

Responsibilities

• Lead and manage clinical trials from start-up to closeout, ensuring compliance with GCP and applicable regulations.
• Coordinate feasibility assessments, protocol activities (screening, recruiting, enrolling, consenting), data and biological specimen management, and monitoring preparation.
• Supervise, train, and mentor research staff; ensure proper conduct, protocol adherence, and consistent application of regulatory and institutional standards.
• Prepare, review, and submit regulatory and IRB documentation; maintain accurate study records and subject logs.
• Track study finances, perform quality control to ensure data integrity, audit readiness, and regulatory compliance.
• Develop and implement standard operating procedures; participate in leadership initiatives; provide expert consultation on clinical research processes and compliance.
• Represent the organization internally and externally and liaise with stakeholders to support efficient trial processing.

Minimum Qualifications

• Bachelor’s Degree
• Master’s Degree (preferred)
• 5 years of clinical research experience with 3 years of clinical research leadership or project management experience

Additional Qualifications

• Regulatory readiness: oversee regulatory preparations prior to sponsor visits and ensure timely completion of action items.
• Document control: maintain regulatory document versions and ensure audit readiness.
• Regulatory submissions: review materials for timeliness and compliance; support quality submissions to IRB and FDA.
• Communication: interact with principal investigators, IRB offices, ORA, OHR, hospital staff, and sponsors to ensure efficient processing of trials.
• Feasibility participation: actively participate in feasibility assessments; manage regulatory documentation workflow.
• Project management: direct regulatory documentation and workflow using PM tools; maintain organized processing for multi-site trials.
• Scope: oversee diverse trial types including multi-site and industry-sponsored studies, investigator-initiated studies, and NCI cooperative group protocols.

Work Environment & Benefits

Location: 1015 Walnut Street, Philadelphia, PA. This role is within Thomas Jefferson University/ Jefferson Health system. Jefferson offers a comprehensive benefits package for full-time and part-time colleagues, including medical, dental, vision, life and disability coverage, retirement plans, tuition assistance, and voluntary benefits. The organization is committed to equal opportunity employment and provides a variety of growth opportunities.