Senior Regulatory Research Coordinator (Sidney Kimmel Cancer Center - Remote Position)

Job Details

Senior Regulatory Research Coordinator (Sidney Kimmel Cancer Center - Remote Position)

Job Description

Job Summary:
The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Trials Office (CTO) is seeking a Senior Regulatory Research Coordinator dedicated to supporting a complex portfolio of investigator-initiated trials. The Senior Regulatory Research Coordinator works under limited supervision and is responsible for the accurate compilation and submission of protocols and related study documents to various internal and external approving committees. These may include the Protocol Review and Monitoring Committee (PRMC), IBC, Radiation Safety, FDA and/or NIH, and the applicable Institutional Review Board (IRB). The Senior Regulatory Research Coordinator is responsible for maintaining electronic 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 electronic regulatory binders / files and ensures appropriate version control is in place.
• Coordinates submissions to ancillary committees such as Radiation Safety and Institutional Biosafety.
• 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.
• Communicating to study teams the importance of adhering to CTO Regulatory processes
• Other duties as assigned

Qualifications:
The ideal candidate will have a HS diploma with 6 years clinical research experience and SOCRA Certification, or a Bachelor’s degree in a scientific or healthcare-related field with at least 2 years clinical research experience, or a Master’s degree in a scientific or healthcare-related field with 1 year clinical research experience.

Additional qualifications include:

• Strong written and oral communication skills, attention to detail, customer service orientation, and proven ability to perform work accurately and efficiently.
• Experience working with grant funded and Investigator-Initiated clinical trials.
• Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials.
• Familiarity with terminology and processes associated with the conduct of clinical research.
• Experience with clinical trial management systems, such as OnCore and ClinicalTrials.gov.
• Demonstrated ability to work independently and with a team.
• Demonstrated proficiency with Microsoft Office, including Outlook, Teams, OneNote, Word, and Excel.
• Regulatory experience is a must at the senior level.

Work Shift

Rotating (United States of America)

Worker Sub Type

Regular

Employee Entity

Thomas Jefferson University

Primary Location Address

1025 Walnut Street, Philadelphia, Pennsylvania, United States of America

Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research.