Sr. Research Program Coordinator II - Regulatory Specialist
Johns Hopkins University
Location: Baltimore, Maryland
Internal Number: 110651-en_US
The Department of Radiation Oncology is seeking a Sr. Research Program Coordinator II - Regulatory Specialist, Who will serve as a central resource for regulatory aspects of faculty conducting clinical research. Working closely with the Program Manager, Research Nurses, Grants and Contracts staff, PIs and sponsors, this position will complete and submit the initial IRB submission for both prospective and retrospective protocols. Prior to the start of a study, will ensure all proper regulatory documents have been approved and that all documents, Case Report Forms, databases, monitoring/auditing requirements have been completed. Will produce and maintain an electronic regulatory binder prior to the study initiation with all required documents and additional sections for future documents. Will work closely with the study coordinators to ensure all documents are submitted to the IRB in a timely manner. Keep up to date on new School of Medicine and SKCCC regulatory guidelines and SOPs and advise the clinical trial team on these requirements.
Specific Duties & Responsibilities
Work closely with the Research Nurses and PI on new studies to ensure timely, accurate submission to the IRB and sponsors.
Assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, SKCCC requirements, etc.
Obtain all required documents for new submissions to the IRB.
Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
Prepare reports and present updates on protocol submission process.
Complete new study IRB submissions.
Ensure smooth implementation of regulatory aspects of new trials from conception through study activation.
Work closely with the Protocol compliance team to ensure all documents are ready prior to a study opening.
For IND/IDE studies, maintain accurate and up-to-date documents and submissions.
Coordinate and attend Clinical Trial Review Committee meetings.
Initiate all clinical trials in the CT.gov system and work with the PI and Program Manager to maintain study information.
Produce and maintain a regulatory binder prior to study starting with all required documents.
Work closely with sponsors to ensure all documents are reviewed, approved and correct prior to a study opening.
Ensure that all continuing reviews are completed and submitted to the IRB in a timely manner.
Act as the lead resource for the clinical trials team in regulatory aspects of clinical trials.
Develop standard operating procedures as needed.
Assist in the auditing and monitoring of studies as needed.
Bachelor's Degree in related discipline.
Five years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Related Master's Degree.
Familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research.
Experience using REDCap and/or OnCore.
Classified Title: Sr. Research Program Coordinator II Working Title: Sr. Research Program Coordinator II - Regulatory Specialist Role/Level/Range: ACRP/04/MC Starting Salary Range: Min $47,500 - Max $83.300 Annually ($65,000 targeted; Commensurate with experience) Employee group: Full Time Schedule: M-F, 8:30am-5:00pm Exempt Status: Exempt Location: Hybrid/School of Medicine Campus Department name: SOM Rad Onc Clinical Trials Group Personnel area: School of Medicine
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
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