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Job Req ID:  17295

Research Program Manager

General summary/purpose:

 

 

We are currently seeking a Research Program Manager to direct the regulatory, implementation and logistical aspects of several research projects that relate to hepatitis C virus (HCV) and HIV infection among people who inject drugs (PWID) in India. The position will involve working with a group of principal investigators and other research staff located both in the US and India. The Research Program Manager will be primarily responsible for oversight of one large randomized control trial of hepatitis C treatment delivery including regulatory submissions, development and maintenance of study protocols and manual of operations, preparation of survey materials and other data collection materials, working with the data management and analysis team to monitor study progress in terms of recruitment goals and outcomes, spearheading compliance considerations on an international drug trial, and leading the preparation of research reports. In addition, there will at times be requests to work with other related projects with the same investigators. The Research Program Manager should be someone who works well in a collaborative atmosphere but also can maintain a high degree of independence from the PIs.

 

 

Specific duties & responsibilities:

 

  • Manage the administrative and scientific implementation of a trial of HCV treatment delivery in India in close collaboration with study Principal Investigators, co-investigators, collaborators and research staff located both in the US and India
  • Develop and maintain study protocols and manual of operations
  • Develop field training guides for use in India
  • Work with the study data manager/biostatistician to develop a study database
  • Monitor all study related activities including those related to study progress with respect to patient accrual, randomization, follow-up, and adverse events
  • Assist with grant submissions, research reports, preparation and execution of regulatory compliance documents.
  • Maintain regulatory compliance per DAIDS and JHU IRB
  • Develop and modify study data collection materials including study surveys, recruitment materials
  • Organize and maintain regulatory files
  • Perform quality assurance and quality control activities
  • Communicate with research teams in India to ensure compliance to the protocol and successful recruitment, follow-up and intervention delivery
  • Communicate regularly with the Principal Investigator, co-investigators and collaborators regarding the progress of the research and management of problems.
  • Take a leadership role in developing tools for tracking study progress and anticipating upcoming objectives, challenges, and solutions to present to the team.
  • Other duties (related research projects)
    • Assist with regulatory activities including IRB reporting for related studies in India as needed
    • Support the development of study protocols, study surveys and recruitment materials and study reports as needed

 

 

Minimum qualifications (mandatory):

 

  • Bachelor's degree in related discipline.
  • 5 years related experience.
  • Demonstrated supervisory or lead responsibilities.
  • Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

 

 

 

Preferred qualifications:

 

  • Master's degree or PhD in related discipline.
  • Desired qualifications include experience with clinical trial implementation and regulatory compliance.

 

 

 

Classified Title: Research Program Manager  
Working Title: Research Program Manager  ​​​​​
Role/Level/Range: ACRP/04/MD 
Starting Salary Range: $52,495 - $72,210
Employee group: Full Time 
Schedule: M-F 37.5 hours/week 
Exempt Status: Exempt  
Location: 05-MD:School of Public Health 
Department name: 10001101-Epidemiology 
Personnel area: School of Public Health

 

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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