The MVAC 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 Principal Investigator. The Nurse Practitioner Manager will work closely with the Principal Investigator and MVAC research team to develop work plans, achieve project goals, and oversee implementation activities in adult human subject vaccine trials according to good clinical practice (GCP) guidelines. The position will manage all aspects of MVAC clinical operations, including interaction with all relevant stakeholders such as government and industry sponsors, collaborators, regulatory affairs, faculty/ staff.
In addition, the Nurse Practitioner 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 Nurse Practitioner Manager is responsible for providing leadership to MVAC 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 and Responsibilities:
Leads clinical operations role for the MVAC team, reporting to the Principal Investigator with oversight of all administrative, financial, and operational aspects of vaccine clinical trials.
Serves 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 the overall MVAC program management of clinical trials in alignment with ICH/GCP guidelines.
Provides leadership in the development of the budget and resourcing strategy at a clinical program level as a Clinical Operations Program Lead.
Collaborates with the Principal Investigator, and faculty 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.
Authors 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. Works with the 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.
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.
Tracks proposals and other documentation through signature/approval processes then through collaboration with Contracts personnel and IRB Navigators.
Serves a critical role as liaison and facilitate meetings between project stakeholders and leadership, completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists 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.
Contributes 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.
Complete other duties as assigned.
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. Require minimum of 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. Current CPR certification required. Must maintain current licensure and certification during duration of employment.
Prefer at least 5 years related experience.
4-6 years supervisory experience preferred.
Understanding of GCPs, FDA regulations and ICH guidelines preferred.
Management of clinical trials or other relevant experience preferred
CPR Certification – can be completed during onboarding
Excellent oral/written communication skills,
Ability to manage complex partner networks is a must.
Ability to communicate in Spanish is preferred but not a must.
Special Knowledge, Skills, and Abilities: Excellent oral/written communication skills, allowing effective interactions with all levels of the organization.
Strong analytical skills for integrating and interpreting interdisciplinary project information.
Knowledge of Microsoft office suite, SharePoint, and TEAMs – training will be provided. Will require data entry into study database – training will be provided. Use of personal computer, fax machine, copy machine, and cellular telephone. Use of oto-ophthalmoscope, sphygmomanometer, stethoscope, and pertinent laboratory equipment as needed for processing subject specimens. Physical Requirements: Sitting, standing and walking for extended period. Reaching by extending hand(s) or arm(s) in any direction. Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s). Occasionally lifting, carrying objects weighing 50 lbs. or less. Occasionally pushing, pulling objects weighing 50 lbs. or less. Ability to move standard equipment through a hospital or clinical environment.
Classified Title:Nurse Practitioner Manager Role/Level/Range: ACRP/04/MH Starting Salary Range: Competitive; Commensurate with experience Employee Group: Full Time Schedule: Monday Friday 37.5 hours/ Occasional evenings and weekends. Exempt Status: Exempt Location: Johns Hopkins Bayview Department Name: International Health, Center for Immunization Research Personnel Area: School of Public Health
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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