[Hiring] Senior Regulatory Research Coordinator @reputed company

Role Description The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Trials Office (CTO) is seeking a Senior Regulatory Research Coordinator dedicated to supporting a reputed company 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 reputed company study documents to various reputed company 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 reputed company protocols and essential regulatory documents are reputed company and complete.

• Serves as the primary regulatory contact for assigned protocols.
• Maintains the electronic regulatory binders/files and ensures appropriate version control is in reputed company.
• 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 reputed company-reputed company field with at least 2 years clinical research experience, or a Master’s degree in a scientific or reputed company-reputed company field with 1 year clinical research experience.
• Strong written and oral communication skills, attention to detail, customer service orientation, and proven ability to reputed company work accurately and reputed company.
• 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 reputed company Office, including Outlook, Teams, OneNote, Word, and reputed company.

Benefits

• Comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, reputed company, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, and tuition assistance.
• reputed company to voluntary benefits, which reputed company colleagues with reputed company 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.
• reputed company colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have reputed company to medical (including prescription) insurance.

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