The FIRE team at the Center for Immunization Research is seeking a Nurse Practitioner Manager to lead the clinical operations for vaccine clinical trials and to work in close collaboration with the Senior Research Associate and Principal Investigator. The NP Manager will work to develop work plans, achieve project goals, and oversee implementation activities in human subject vaccine trials according to good clinical practice (GCP) guidelines. The position will manage all aspects of FIRE clinical operations, including interaction with all relevant stakeholders such as government and industry sponsors, collaborators, regulatory affairs, faculty, and staff. In addition, the NP Manager will serve as an integral role of the team, functioning as a clinician on the clinical trials.
The ideal candidate in this position will be an experienced clinician, clinical operations and development leader, able to thrive in relatively uncertain environments, tolerate ambiguity, be willing to innovate, problem solve and to embrace and overcome the development challenges and complexity associated with vaccine clinical trials. The NP Manager is responsible for providing leadership to FIRE team's current programs and ensuring studies (Phase I-IV) are compliant with the team and the Center's overall program goals, timeline, budget and quality expectations. This individual is responsible for ensuring clinical trials are aligned with and in compliance with the Center's procedures, FDA, regulations, GCP, ICH requirements and any other applicable regulations. This position is also responsible for the development and implementation of clinical operations standards and for identifying areas for improvement and clinical project management.
Specific Duties & Responsibilities
Lead clinical operations role for the FIRE team, reporting to the Senior Research Associate with oversight of all administrative, financial, and operational aspects of vaccine clinical trials.
Serve as a Clinician on the clinical trials, evaluating potential volunteers, performing physical exams and clinical assessments, and following volunteers throughout the clinical trial for safety.
Responsible for clinical trials in alignment with ICH/GCP guidelines.
Collaborates with the Senior Research Associate, Principal Investigator, and faculty/staff of other teams to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.
Participates and/or leads continuous improvement initiatives and collaborates in the development of Clinical Operations Standard Operating Procedures (SOP), training, and other tools to ensure compliance with FDA Regulations.
Provides ongoing performance review, feedback and development of staff.
Creates a talent management plan to address individual performance needs as well as establishes a succession plan for the team.
Ensures effective performance management process is in place and specific development plans are implemented for each team member.
Contributes to the clinical operations strategy including resourcing considerations and oversight models.
Supports high quality decision-making by ensuring relevant research, analysis, and expertise is available as required.
Delivery of key clinical milestones ensuring proactive risk mitigation and issue escalation.
Author key documents as needed to conduct clinical trials.
Communicates key elements of clinical strategy, issues, and plans to internal and external stakeholders as needed.
Identifies the required resources for project success, influence optimal team composition, align goals and objectives with team members. Work with the Senior Research Associate and Principal Investigator to help them meet targets and milestones (ensure timely and accurate submission to IRBs, sponsors and master agreements). 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 team by ensuring smooth implementation of new trials from conception through study activation.
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.
Tracking proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators.
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.
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.
Contribute to development of protocol documents including consent forms, source documents, CRFs and data collections tools, and monitors implementation compliance. Ensures that all clinical trial related activity is performed in compliance within GCP, ICH, IRB guidelines, and other pertinent regulatory agencies.
May be responsible for recruiting, screening, educating, obtaining informed consent. Studies are conducted in inpatient and outpatient settings.
Performs job functions independently and within a team structure.
Completion of other duties as assigned.
Special Knowledge, Skills & Abilities
Proven ability to work cross-functionally with interdisciplinary teams to access and optimize resources for development programs and experience working in a matrix organization.
Strong track record of producing results in a high energy research-driven environment.
Excellent oral/written communication skills, allowing effective interactions with all levels of the organization. Strong analytical skills for integrating and interpreting interdisciplinary project information.
Ability to manage complex partner networks is a must.
A high degree of organizational awareness and the ability to successfully interact with internal and external scientists as well as a strong commitment to the Johns Hopkins mission.
Will require use of Microsoft Office Suite and TEAMs – training will be provided. May require data entry into study databases – training will be provided. Personal Computer, fax machine, copy machine, cellular telephone, Oto-ophthalmoscope, sphygmomanometer, stethoscope, and pertinent laboratory equipment as needed for processing subject specimens.
Master's Degree in nursing, Registered Nurse license and Certified as a Nurse Practitioner. Must be licensed as NP in State of Maryland or other state where practicing.
3 years experience in related clinical area, and obtained proficiency in area of specialty.
Residency or fellowship programs in area of specialization may substitute for some experience
Five years of clinical research and/ or related experience and program management experience.
Management of clinical trials or other relevant experience.
Experience with program management methodology and tools.
Four years of prior supervisory experience .
Understanding of GCPs, FDA regulations and ICH guidelines.
CPR Certification – can be completed during onboarding
Classified Title: Nurse Practitioner Manager Role/Level/Range: ACRP/04/MH Starting Salary Range: $98,530 - $135,470 (Commensurate with experience) Employee group: Full Time Schedule: Mon - Fri 8:30 am - 5:00 pm / 7.50 hrs./day Exempt Status: Exempt Location: School of Public Health Department name: Ctr for Immnztn Rsch Vaccine Scis CIR Personnel area: School of Public Health
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:
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.
The successful candidate(s) for this position will be subject to a pre-employment background check.
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.
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 [email protected]. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
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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