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Job Req ID:  114311

Sr. Research Program Coordinator

We are seeking a Sr. Research Program Coordinator who, under minimal supervision, will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. 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 Program 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 Program 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 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 program 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 Program Coordinator and research assistant to review all documents prior to study activation.
  • Participates in 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 Program Coordinators and 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. 
  • Three years related experience.
  • Additional education may substitute for experience.



Preferred Qualifications
  • Master's Degree preferred.
  • Certification as a Clinical Research Professional is preferred.

 

 

Classified Title: Sr. Research Program Coordinator 
Job Posting Title (Working Title): Sr. Research Program Coordinator   
Role/Level/Range: ACRP/03/MB  
Starting Salary Range: $40,900 - $71,600 Annually (Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F, 830-500 
Exempt Status: Exempt 
Location: Hybrid: On-site 3-4 days a week 
Department name: 10002941-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.
Hybrid: On-site 3-4 days a week

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