Clinical Research Project Manager - Study Start Up Specialist

Thomas Jefferson University & Jefferson Health; Philadelphia (Philadelphia County); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player is seeking a detail-oriented Clinical Research Study Start-Up Specialist to manage the initiation of clinical trials. This role requires strong organizational skills and collaboration with various teams to ensure compliance with regulatory standards. You will lead the start-up phase, oversee documentation, and train staff, making a significant impact on the success of clinical research projects. Join a dynamic team dedicated to advancing healthcare through innovative research practices and contribute to meaningful studies that improve patient outcomes.

Qualifications

• 5+ years of clinical research experience or 3+ years with a Master's degree.
• Strong understanding of regulatory requirements and GCP standards.

Responsibilities

• Lead start-up phase of clinical trials and ensure compliance.
• Train and supervise research staff on proper procedures.

Skills

Clinical Trial Management

Regulatory Submissions

Site Selection

Problem-Solving

Training Staff

Education

Bachelor's Degree

Master's Degree

High School Diploma

Tools

Electronic Capture Databases

Job description

Job Details

Jefferson Clinical Research Institute (JCRI) seeks a highly motivated and detail-oriented Clinical Research Study Start-Up Specialist to join our dynamic team. The ideal candidate will be responsible for managing and overseeing the start-up phase of clinical trials, ensuring that all required regulatory, site, and logistical components are completed in a timely and efficient manner. This role requires strong organizational skills, a deep understanding of clinical trial processes, and the ability to collaborate with cross-functional teams to ensure smooth and successful study initiation. The role works with minimal supervision and serves as the main contact for all trial start-up activities across multiple departments, including preparation for monitoring visits and regulatory and IRB document preparation. The specialist ensures all study procedures are conducted according to the protocol and applicable regulations. Responsibilities include training research staff, supervising staff, overseeing clinical trials from start-up to closeout, developing or contributing to standard operating procedures, attending leadership meetings, representing TJU internally and externally, overseeing research operations, and providing expert consulting at an institutional level.

Job Description

Essential Functions:

• Interact with co-workers, visitors, and other staff consistent with the values of Jefferson.

Study Start-Up Coordination:

• Lead and coordinate all activities related to the start-up phase of clinical trials, including feasibility, site selection, regulatory submissions, committee approvals, and site training.
• Ensure all documentation is accurate, complete, and compliant with regulatory requirements, including IRB submissions, informed consent forms, and investigational product documentation.
• Identify and problem-solve potential roadblocks to success.
• Oversee and participate in the build of study workflows and timelines.

Regulatory and Compliance:

• Oversee and participate in the preparation and submission of regulatory documents, including approvals, applications, investigator brochures, and other essential regulatory submissions.
• Collaborate with internal and external stakeholders (sponsors, CROs, PIs, IRBs, approval committees) to ensure timely approvals.

Site Management:

• Work closely with site personnel to ensure timely initiation of clinical study sites, including contracting, budget negotiation, and site feasibility assessments.
• Train and supervise research staff on proper procedures per GCP.
• Review effort reports of site personnel and analyze start-up processes for accuracy and efficiency.
• Perform regular quality control assessments to ensure data collection and storage adhere to GCP and JCRP standards.
• Design or assist in designing electronic capture databases and manage collected data.
• Provide clerical and technical support to ensure adherence to research protocols and data quality.

Minimum Education and Experience Requirements

Minimum High School Diploma or equivalent.

AND

Experience:

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

Work Shift

Day shift (United States of America)

Worker Sub Type

Regular

Primary Location Address

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