Research - Laboratory/Non-Laboratory, Staff/Administrative
The Research Program Manager (RPM) will develop work plans to achieve assigned project goals and organize activities with collaborative sites in support of project goals. This includes training and managing collaborative site personnel and other trial site personnel regarding fidelity of protocols and data collection for the specific assigned process metrics used in the trial under management.
The RPM will have the critically-important responsibility for establishing early lines of communication with the clinical teams as they are selected and prepared for activation. The RPM will be integral to propel the subject accrual and monthly goals of enrollments per month across all sites. S/He will assist with site evaluations detailing the availability of critical local resources necessary to be successful at enrollment and protocol performance once the trial begins. S/He will assist sites in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
During trial implementation, the RPM will oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion. S/He will conduct monthly (or more frequent) teleconferences with the clinical teams and individually mentor new coordinators. The RPM is critical to keeping enrollments on track with established performance expectations. The RPM will also provide support for quality assurance monitors in all facets of work related to communications with and management of the enrolling center clinical teams.
The RPM will execute project management processes and methodologies to ensure projects are delivered on-time and within the budget, adhere to high quality standards, and benefit the investigative teams by ensuring smooth implementation of new trials from conception through study activation.
The RPM will be responsible for assembling project plans, team and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately. The RPM will also be responsible for managing investigator relationships.
The RPM will be responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators.
The RPM will serve a critical role as liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop SOPs as needed, and assist in the auditing and monitoring of studies.
The RPM will use professional judgment in handling information and be sensitive to project team, individual and all levels of organizational concerns; make use of data, statistical and quantitative analysis, explanatory and predictive modeling and fact-based management to drive decision making; and help investigators develop new insights and understanding of performance-based data.
Bachelor’s degree in Biology, Chemistry or a related field required.
Five (5) years of related experience in delivering effective project management solutions and Demonstrated supervisory or lead responsibilities required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits (semester hours) 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.
Master’s Degree in related field preferred.
Special Knowledge, Skills, and Abilities:
Animal Project/system process lifecycle experience, including 2+ years of direct project management.
Excellent leadership skills with ability to negotiate and work collaboratively; service-oriented with excellent verbal and written communication and organization skills; knowledge of formal project management methodologies; experience in a higher education environment.
Understands and can apply knowledge of clinical trial designs to trial execution
Advanced knowledge and experience with GCP/ICH and local regulations
Experience in web-based data collection applications
Ability to prioritize own work and work of others as needed.
Strong organizational skills, analytical and problem solving abilities, and attention to detail
Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines
Classified title: Research Program Manager
Working title: Research Program Manager
Role/Level/Range: ACRP 37.5/E/04/MD
Starting Salary Range: $52,494.96 - $72,212.64 (commensurate with experience)
Employee group: Fulltime
Employee Status: Exempt
Schedule: Monday-Friday –8:30am-5:00pm 37.5hrs/Wk
Location: SOM Campus – Baltimore, MD
Department name: 10003520-SOM Neuro BIOS
Personnel area (School): SOM – 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 HR Business Services Office at email@example.com. 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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