[Hiring] Senior Regulatory Research Coordinator @Jefferson Health Plans
Role Description
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.
• 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.
• Communicates to study teams the importance of adhering to CTO Regulatory processes.
• Other duties as assigned.
Qualifications
• 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.
• 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.
Benefits
• 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, and tuition assistance.
• Access to voluntary benefits, which provide colleagues with access to group rates on insurance and discounts.
• 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.
Apply tot his job
Apply To this Job
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.
• 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.
• Communicates to study teams the importance of adhering to CTO Regulatory processes.
• Other duties as assigned.
Qualifications
• 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.
• 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.
Benefits
• 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, and tuition assistance.
• Access to voluntary benefits, which provide colleagues with access to group rates on insurance and discounts.
• 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.
Apply tot his job
Apply To this Job