Research - Laboratory/Non-Laboratory, Staff/Administrative
The Department of Radiation Oncology is seeking a regulatory specialist that 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.
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 required.
Five (5) years of related experience required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits (semester hours) may substitute for one year of experience. 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.
Related Master’s Degree preferred.
Special Knowledge, Skills, and Abilities:
Must have familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research.
Excellent verbal and communication skills are required.
Technical qualifications or specialized certifications:
SOCRA, Certified IRB Professional or other clinical research certifications are preferred.
Classified title: Sr. Research Program Coordinator II
Working title:Sr. Research Program Coordinator II - Regulatory
Role/Level/Range: ACRP 37.5/E/04/MC
Starting Salary Range: $45,195.12 - $62,225.04 (commensurate with experience)
Location: CRB II, 4M - 1550 Orleans St., Baltimore MD
Department name: 10003153-SOM Rad Onc Clinical Trials Group
Personnel area (School): SOM – School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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