Research Program Manager (DOM Infectious Disease)

The Division of Infectious Diseases is seeking a Research Program Manager who will oversee programmatic and administrative aspects of the Rapid Acceleration of Diagnostics Program funded through the NIH in the Center for Innovative Diagnostics for Infectious Diseases. (CIDI) The Job will require understanding of and experience with reference laboratory assays, point-of-care devices, and interface with both the sponsor and medical technology device companies to accelerate development toward FDA clearance. This position is responsible for all company-facing liaison activities. This includes; initial contact meetings (scheduling, executing non-disclosure agreement for initial meeting, follow-up of action items); linking companies to CIDI resources under materials transfer agreements, data use agreements, protocols, and regulatory compliance; SBIR application requests; annual solicitation oversight with follow-up of the 3-6 companies that get awards matching progress to pre-specified milestones and timelines; annual CIDI showcase event planning, resource mobilization and maintain CIDI website. All of these activities are to accelerate the development of point-of-care diagnostics for infectious diseases.

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Research Program Manager works under the general supervision of a Pl{s) to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites. As part of a study team, collaborate with faculty, develop protocols, develop SOPs, and supervise study-related activities for one or more studies. Has accountability for grant submission and administration, and regulatory compliance. Supervise or oversee other exempt-level research staff; may oversee staff at local or multi-center sites.

Specific Duties & Responsibilities

Partner with investigator(s) and exercise independent judgment in managing the conduct of the research on behalf of the Pl.
Participate in scientific discussions with collaborators, PIs, and funding organizations.
Collaborate with Pl to ensure operational feasibility of proposed protocol/study design.
Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s).
Develop or oversee the development of consent form(s) for clinical trials based on protocol(s).
Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the PI.
Train and provide oversight of research data management and regulatory issues.
Work with commercial and/or government agency sponsors to determine which group can commit to considering patient population, available resources, and cost of providing services.
Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
Ensure clinical research protocol has a completed Prospective Reimbursement Analysis (PRA) and processes/systems are in place to ensure the PRA is followed when required.
Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials.
Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures for the efficient collection of data.
Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial.
Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
Contribute to presentations and manuscripts.
Hire, supervise, and manage the performance of other exempt-level research staff.
Other duties as assigned.

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.
Demonstrated supervisory or lead responsibilities.

Preferred Qualifications

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

Classified Title: Clinical Research Manager
Job Posting Title (Working Title): Research Program Manager (DOM Infectious Disease)
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($76,700 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30am -5pm
FLSA Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM DOM Infectious Disease
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 requires all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the 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.

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

Apply now »