Clinical Research Coord Senior - JCRI

Thomas Jefferson University & Jefferson Health; Philadelphia (Philadelphia County); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player in healthcare is seeking a dedicated Clinical Trial Manager to oversee the daily operations of clinical trials. This role involves ensuring compliance with Good Clinical Practice (GCP), managing data, and training research staff. You will play a crucial part in the successful execution of clinical studies, from protocol coordination to regulatory submissions. If you are passionate about advancing clinical research and ensuring data integrity, this opportunity offers a dynamic environment where your contributions will be valued and impactful.

Qualifications

• Experience in overseeing clinical trials and ensuring compliance with GCP.
• Proficient in data management and regulatory document preparation.

Responsibilities

• Oversee day-to-day activities of clinical trials in accordance with GCP.
• Train and supervise staff on proper clinical trial procedures.
• Prepare and submit materials for IRB and regulatory compliance.

Skills

Clinical Trial Management

Good Clinical Practice (GCP)

Data Management

Regulatory Compliance

Staff Training

Education

Bachelor's Degree in Life Sciences

Certification in Clinical Research

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). Responsible for 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/or 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 the development of workflows, training documents, SOPs, and guidance document revisions. Participates in work groups.

Job Description

Essential Functions:

1. Interacts with co-workers, visitors, and other staff consistent with the values of Jefferson.
2. Oversees the day-to-day activities of a clinical trial in accordance with GCP.
3. Trains and supervises research staff on proper procedures for conducting a clinical trial per GCP.
4. 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 manner.
5. Maintains accurate subject logs, tracks expenses, and submits appropriate documentation to the Grant Administrator monthly for payment processing related to study visits.
6. Performs regular quality control assessments to ensure clinical trial data is collected and stored per GCP.
7. Organizes and maintains documentation of all patient data.
8. Designs electronic data capture databases, if appropriate, and manages all collected data.
9. Provides clerical and technical support to ensure adherence to research protocols and data quality.

Work Shift

Day shift (United States of America)

Worker Sub Type

Regular

Primary Location Address

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