Clinical Research Coordinator Sr. (Remote)

About the role

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 Summary

The Sidney Kimmel Comprehensive Cancer Center (SKCCC) is seeking a Clinical Research Regulatory Coordinator dedicated to sponsor and investigator-initiated trials. The position reports to a Regulatory Manager within the Research Support Service team of the Clinical Trials Office and provides regulatory support for oncology clinical research studies.

The Regulatory Coordinator is responsible for the accurate compilation and submission of protocols and related study documents to the Protocol Review and Monitoring Committee (PRMC) and applicable Institutional Review Board (IRB), and for maintaining regulatory study files to ensure all protocols and essential regulatory documents are current and complete.

Primary Responsibilities

• Serves as the primary regulatory contact for assigned protocols.
• Maintains the regulatory binders/files and ensures appropriate version control is in place.
• Coordinates submissions to ancillary committees such as Radiation Safety.
• Communicates with the IRB and Sponsor on behalf of the study team regarding regulatory management.
• Collaborates with the study team and sponsors to finalize documents based on PRMC and/or IRB recommendations.
• Prepares and submits study amendments and continuing review applications for PRMC and IRB review.
• Prepares regulatory files for auditing and monitoring visits.

Minimum Qualifications

• High School Diploma/GED
• 5 years High School Diploma/ GED and SoCRA 6 years of clinical research experience or
• 2 years with Bachelor's degree and 2 years of clinical research experience or
• 1 year with Master's Degree and 1 year clinical research experience.

Physical Demands

Lift and carry 40-50 lbs. Examples: Push/pull patients on bed, stretcher (requires 29 lbs. push force), lateral transfers up to 50 lbs. of the patient's weight. Frequent to continuous standing/walking. Patient transporters can walk 8-10 miles per shift. *Patient care providers may be required to perform activities specific to their role including kneeling, bending, squatting and performing CPR.

Benefits

Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts.

Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance.

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