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Job Req ID:  82480

Sr. Research Program Supervisor

The Oncology Department is seeking a Senior Research Program Supervisor  who will work under limited supervision of the Sr. Clinical Research Program Manager and Program Directors. This role is responsible for monitoring the clinical course and collection of research data on patients entered onto research protocols for the Sibley Clinical Research Program and participating sites. 

 

The Sr. RPC Supervisor is 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. This requires a high level of knowledge, oversight, and organization, and will serve as a central resource for faculty conducting clinical research. The Sr. RPC Supervisor also has supervisory responsivities of hire, fire, discipline and coaching of two or more Research Program Assistants and/or Research Program Coordinators at Sibley and assist with general operations of the program.

 

Specific Duties & Responsibilities:

  • 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.
  • Coordinate complex industry-sponsored clinical trial protocols, including regulatory management, data management, event reporting, and relation management with sponsor representatives and service center cores.
  • 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.
  • Track each site through local regulatory review and contract execution process, evaluate for recurrent problems, development and implement systems to decrease delay in site activation process.
  • Collect and review regulatory documents from participating sites prior to study activation, conduct study start-up meetings, maintain communication with sites to ensure high quality of data, timely submission of data, and adherence to guidelines.
  • Review subject eligibility and registration request.
  • Conduct on-site training and monitoring visits as needed.
  • For IND studies, maintain accurate and up-to-date documents and submissions to FDA and ClinicalTrials.gov reporting.
  • Facilitate the full cycle of the protocol approval process – development, submission, contract negotiation, budget development, interaction with Cancer Center Cores.
  • Assist PI with abstracts and manuscripts preparation.
  • When needed, recruit, train, and supervise entry-level research data management and regulatory personnel within the program, such as Research Program Assistants and Research Program Coordinators.
  • Assist Sr. Clinical Research Program Manager with program operations – providing suggestions for improved procedures, creating checklists and program-related Standard Operating Procedures.
  • Assists with study budget and invoice preparation as needed.
  • 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.
  • 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.

 

 

This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s). It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.

         

Supervision of Others:

  • Supervisory responsivities of hire, fire, discipline and coaching of two or more Research Program Assistants and/or Research Program Coordinators.

 

Equipment, Machine, or Tool Requirements: 

  • General computer skills, with experience with Microsoft Office

 

Minimum Qualifications (Mandatory):

  • BA/BS Degree in Biological/Social Sciences or other appropriate discipline required. Additional graduate level course work is preferred.
  • Minimum three years’ experience in complex and detailed clinical trials/medical research required.
  • Additional graduate level courses may substitute for some work experience. Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula.*
  • Proficiency in the use of software applications, databases, spreadsheets, and word processing required.

 

JHU Equivalency Formula: 18 graduate degree credits 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. 

 

**  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. 

 

Licensure, Certification, Registration:

  • Certification as a Clinical Research Professional is preferred.

 

Special Knowledge, Skills, or Abilities:

  • Knowledge of clinical research practices and principles required.
  • Excellent organizational skills required.
  • Excellent attention to detail skills required.
  • Knowledge of medical terminology required.
  • Familiar with medical procedure and laboratory fees.
  • Ability to manage multiple and competing priorities.
  • Ability to understand a clinical trial financial contract.
  • Must have excellent time management skills.
  • Must have excellent oral and written communication skills.

 

Additional Requirements:

  • Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
  • Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
  • Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.

 

Classified Title: Sr. Research Program Supervisor
Role/Level/Range: ACRP/03/MC 
Starting Salary Range: $45,650 - $62,850 annually (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 Onc Clinical Trials 

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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

 

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. 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.

 

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