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Requisition ID:  118097

Sr Research Program Coordinator

Under limited supervision of the Clinical Research Program Manager, we are seeking a Sr. Research Program Coordinator who will be responsible for study site activation and management, including regulatory review, site study team training, data monitoring and integrity management, patient enrollment, and overall project timeline management for the Genitourinary Oncology Clinical Research Program. This requires a high level of knowledge, oversight, and organization, and will serve as a central resource for faculty conducting clinical research. Responsibilities will also include orient and train research staff in the program and assist with general operations of the program.


Specific Duties & Responsibilities

  • Assists the Start Up Specialist new study IRB submissions as needed.
  • Ensures smooth study activation by working closely with the start-up specialist, PI and research RN and collecting all regulatory documentation.
  • Work closely with the Protocol compliance team to ensure all documents are ready prior to a study opening.
  • Produce and maintain a regulatory binder prior to study starting with all required documents.
  • Work closely with sponsors to ensure all regulatory documents are reviewed, approved and correct prior to a study opening.
  • Ensures all documents are being collected in a timely manner and all regulatory binders are up to date. Meets with Program Coordinator and data assistant to review all documents prior to study activation.
  • Establishes 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, including external sites.
  • Work closely with the Research Nurse, PI and study coordinators on protocol amendments to ensure timely, accurate submission to the IRB and sponsors.
  • Obtain all required documents for protocol amendments to the IRB. And assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
  • Tracks each protocol amendment through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
  • Coordinate the conduct of multicenter clinical trial protocols, including study site selection and activation, patient enrollment, electronic case report form design, specimen shipping, data monitoring, safety review, and other protocol-related tasks.
  • Assist with protocol development and revision of investigator-initiated multicenter studies: Assure protocols, amendments, consent forms, and study operation manuals have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc..
  • For IND studies, maintain accurate and up-to-date documents and submissions.
  • Assist PI with abstracts and manuscripts preparation.
  • When needed, recruit and train research data management and regulatory personnel within the Program.
  • Provide checklist of regulatory and essential documents and ensure these are maintained in e-reg binder for JHU.
  • Assist multi-site specialist with site selection, regulatory document collection, source data verification, budgets and CTA execution.
  • Maintain a continued high level of expertise in institutional databases including Epic, CRMS, eIRB, using this proficiency to ensure accurate data and analysis are sustained for all trials within the program.
  • Assist Clinical Research Program Manager with program operations – providing suggestions for improved procedures, creating checklists and program-related Standard Operating Procedures.
  • Participate as requested in Cancer Center events such as training and orientation for new research staff, testing of CRMS database updates and modules.
  • 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. 
  • Three years of related experience.
  • Additional education may substitute for required experience and additional related experience may substitute for required education beyond High School Diploma or graduation equivalent, to the extent permitted by the JHU equivalency formula.


Preferred Qualifications
  • Certification as a Clinical Research Professional is preferred.

 

 

Classified Title: Sr. Research Program Coordinator 
Role/Level/Range: ACRP/03/MB  
Starting Salary Range: $41,300 - $72,300 Annually ($65,000 targeted; Commensurate w/exp.) 
Employee group: Full Time 
Schedule: Mon - Fri / 830a - 5pm 
FLSA Status: Exempt 
Location: School of Medicine Campus 
Department name: SOM Onc Urologic Oncology  
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. 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/.

Education and Experience Equivalency
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 Completing Studies
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.

Background Checks
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.

Diversity and Inclusion
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
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.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 https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. 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. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. 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 upon 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.
School of Medicine - East Baltimore Campus

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