Career Center

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.

The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

Accommodation Information

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. The COVID-19 vaccine does not apply to positions located in the State of Florida. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

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.

Note: Job Postings are updated daily and remain online until filled.

About Johns Hopkins University

Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.

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