Create Alert
Apply now »
Requisition ID:  119007

Research Program Manager (Research Vice Dean)

We are seeking a Research Program Manager who will help develop and lead a centralized shared resource in the Office of Clinical Trials (OCT) for the School of Medicine (SOM) and oversee a team responsible for facilitating start-ups of commercially sponsored clinical studies.


The team will assist Principal Investigators and study teams by coordinating regulatory and finance/budgeting activities critical to the study start-up phase. Regulatory activities include site evaluation visits, feasibility surveys, initial applications to the IRB and other regulatory agencies, and internal quality control of regulatory document management. Finance/budgeting activities include contracting, budget development, and costing. The manager and team will interact with internal SOM and OCT teams and external stakeholders to efficiently manage each stage of the start-up process.


Specific Duties & Responsibilities

  • Manage the recruitment, education, training and supervision of the regulatory and support personnel within the program.
  • Manage the end-to-end start-up process for commercially sponsored clinical studies, from receipt of a regulatory packet through protocol training and activation.
  • Manage the day-to-day operations to streamline study start-up and maximize efficiencies while ensuring adherence to best practices, regulations, guidelines, and Standard Operating Procedures for human subject's protections and protocol integrity.
  • Ensure the timely completion of the regulatory packet and proactively manage and remove barriers to study site activation.
  • Facilitate effective teamwork and communication among all internal stakeholders, e.g. program staff, research study teams, OCT teams, JHM IRB, SOM and JHU central resources
  • Assess feasibility and operational needs of new studies.
  • Provide support, guidance, and training to study teams to facilitate each step in the start-up process.
  • Develop and implement systems for monitoring, reporting, and quality assurance activities.
  • Communicate with, and track activities led by, internal and/or external research team members and collaborators.
  • Monitor, track, and report critical study start-up milestones, e.g, IRB activities, processing and finalization of contracts, drafting of a complete budget, etc.
  • Serve as liaison between study teams and central research administrative teams.
  • Develop and refine standard operating procedures for study start-up activities.
  • Collaborate with the Office of Research Administration in the coordination and initiation of contracts and budgets for new studies.
  • Contribute to meetings with program stakeholders and provide status updates and recommend changes to operations based on results and goals.
  • Meet with institute- and department-based research councils, PIs, and research staff to address needs and concerns regarding study start-up.
  • Keep OCT leadership apprised of concerns, and action plans as appropriate.
  • Represent the Accelerated Study Start-up Program at institute- and department-based research councils and other committees, tasks forces, and working groups as assigned or requested.


Minimum Qualifications
  • Bachelor's Degree in a related field.
  • Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
  • Experience with implementation of study start-up activities in interventional clinical trials.
  • Supervisory or lead experience.
  • Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.


Preferred Qualifications
  • Master's Degree in a related field.
  • Certification as a Clinical Research Professional.

 

 

Classified Title: Accelerated Study Start-up Program Mgr. 
Job Posting Title (Working Title): Research Program Manager (Research Vice Dean)   
Role/Level/Range: ACRP/04/MD  
Starting Salary Range: $55,800 - $97,600 Annually (Commensurate w/exp.) 
Employee group: Full Time 
Schedule: M-F/8:30 am - 5 pm 
FLSA Status: Exempt 
Location: Remote 
Department name: SOM Admin Res Clinical Research Contract   
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.
Remote

Apply now »