Clinical Research Coordinator Sr.; Hybrid

Number of Positions In Requisition

1

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). Runs 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. Ensuring all study procedures are conducted according to the protocol and applicable regulations.

May also assist with the orientation and training of new staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups.

Job Description

Summary
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). Runs 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. Ensuring all study procedures are conducted according to the protocol and applicable regulations.

May also assist with the orientation and training of new staff. Assists in the development of workflows, training documents, SOP/guidance document revision. Participates in work groups.

Job Duties

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

Minimum Qualifications

• High School Diploma/GED and SoCRA certification and six years of clinical research experience; or
• Bachelor’s degree and two years of clinical research experience; or
• Master’s degree and one year of clinical research experience.

• Four or more years of clinical research experience.
• Experience in clinical research coordination, clinical data management, clinical trial monitoring, quality assurance, or a related area.
• Experience with clinical trial audits, regulatory inspections, GCP, and applicable clinical research regulations.
• Oncology clinical research experience.
• Experience developing or delivering training and preparing standard operating procedures or guidance documents.

Jefferson Building / 1101 Market Street area, Philadelphia, PA, as applicable to the approved Workday location and department’s operational requirements.

This is a hybrid position. Following completion of training and demonstrated ability to work independently, employees are typically expected to work onsite three days per week and remotely two days per week. Additional onsite work may be required based on operational needs, including during major audits or FDA inspections. The position is…