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

Job Details

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 Bachelors degree in a scientific or healthcare-related field with at least 2 years clinical research experience or a Masters 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 .
• 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

Worker Sub Type

Employee Entity

Primary Location Address

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 65000 people strong dedicated to providing the highest-quality compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrows professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic clinical and applied research. Thomas Jefferson University home of Sidney Kimmel Medical College Jefferson College of Nursing and the Kanbar College of Design Engineering and Commerce dates back to 1824 and today comprises 10 colleges and three schools offering 200 undergraduate and graduate programs to more than 8300 students. Jefferson Health nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years.

Jefferson is committed to providing equal educational and employment opportunities for all persons without regard to age race color religion creed sexual orientation gender gender identity marital status pregnancy national origin ancestry citizenship military status veteran status handicap or disability or any other protected group or status.

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 diemcolleagues adjunct faculty and Jeff Temps) have access to medical (including prescription) insurance.

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