Sr. Research Program Coordinator II

Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.

We are seeking a Sr Research Program Coordinator II to work under the Program Manager in GU Oncology Programs. The Sr. Research Program Coordinator II will work under minimal supervision and will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. The candidate will serve as a central resource for faculty conducting clinical research. Preferred candidates should demonstrate excellent communication and organizational skills and the ability to work well independently. Working closely with the Program Manager, Start-up Specialist, Research Nurse and Study Coordinators, this position will assist with the initial IRB submission. Prior to the start of a study, will ensure all proper regulatory documents have been approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed. Will produce and maintain a regulatory binder prior to the study starting with all required documents and additional sections for future documents. Works closely with the Study Coordinators to ensure all documents are submitted to the IRB in a timely manner.

Specific Duties & Responsibilities

• Work closely with the research nurse, PI and study coordinators on protocol amendments to ensure timely, accurate submission to the IRB and sponsors.
• Assure investigator-initiated protocol amendments have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
• Assist in development of Red Cap database for investigator-initiated studies prior to study activation.
• Obtain all required documents for protocol amendments for the IRB.
• Submit and track each protocol amendment through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process.
• Assists the Start Up Specialist with new study IRB submissions as needed.
• Ensures smooth study activation by working closely with the Startup Specialist, PI, research RN and study coordinators to collect all regulatory documentation.
• For IND studies, maintain accurate and up-to-date documents and protocol amendment submissions.
• Produce and maintain a regulatory binder prior to study starting with all required documents.
• Work closely with all sponsors to ensure all regulatory documents are reviewed, approved and correct prior to a study opening.
• Ensure all documents are being collected in a timely manner and all regulatory binders are up to date. Meet with study coordinator and research assistant to review all documents prior to study activation.
• Develop and conduct regulatory training for study coordinators and staff.
• Lead regular meetings with PI, research RN and study coordinator to discuss protocol amendments, deviation and AE logs and patient updates.
• Assist CRO in the auditing and monitoring of studies.
• Assist study coordinators and a research assistants in preparation and conduct of monitoring visits.
• Maintain a continued high level of expertise in institutional databases including Epic, EPR, OnCore, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
• Participate as requested in Cancer Center events such as training and orientation for testing of OnCore database updates and modules.
• Attend monthly CRO Regulatory Specialist meeting.
• Complete minimum requirements for continuing education units. Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies.
• Ensure that Cancer Center policies, Standard Operating Procedures, and guidelines related to the conduct of clinical trials are followed.

Minimum Qualifications

• 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.

Preferred Qualifications

• Related Master's preferred.

Classified Title: Sr. Research Program Coordinator II
Role/Level/Range: ACRP/04/MC
Starting Salary Range: $48,000 - $84,100 Annually ($66,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: M-F/8:30-5:00
Exempt Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: ​​​​​​​SOM Onc Urologic Oncology
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

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 HR Business Services Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

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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