Classified Title: Research Nurse Manager
Working Title: Sr. Clinical Research Program / Research Nurse Manager
Starting Salary Range: Commensurate with Experience
Employee group: Full Time
Exempt Status: Exempt
Location: East Baltimore Medical Campus
Department name: Oncology
Personnel area: School of Medicine
The Senior Clinical Research Program/Research Nurse Manager will be responsible for the overall management of the clinical trials portfolio and clinical research activities within the Hematologic Malignancies Program. The candidate will be responsible for managing research staff (research nurses, study coordinators, and regulatory specialists), developing and implementing effective clinical trials management strategies; including data management and regulatory procedures, research nursing care, and providing education to research staff to ensure that all members of the research staff are properly trained. Candidate will have a dual reporting relationship to the Co-Directors of the Clinical Research Operations and the Clinical Research Program Manager.
DUTIES AND RESPONSIBILITIES
Responsible for the recruitment, education, training and supervision of the research nursing, research data management and regulatory personnel within the Program.
Actively manages personnel within research data management:
Assesses staff workload and determines DM assignments
Facilitates effective teamwork between research nursing, study coordinators, and regulatory personnel
Conducts performance appraisals for research nurses, study coordinators, and regulatory personnel, and other staff within the research program
Responsible for recruiting and hiring study coordinators, research nursing personnel, and regulatory specialists.
Responsible for development and implementation of policy and procedures for the clinical research within the Division of Hematologic Malignancies
Directs a weekly meeting with Research Program Management to discuss the current and upcoming clinical trials portfolios, active research issues, and staffing needs
Meets regularly with Co-Directors of the Clinical Research Operations to discuss availability of resources and prioritization of protocols
Supervises space allocation within the designated work area
Facilitates collaboration between Hospital and University personnel including data management, inpatient, outpatient and research nursing, house staff and faculty.
Assists PI with clinical protocol development, including reviewing and assessing new protocols for clarity, thoroughness, logistical feasibility, maintaining subject safety etc.
Assists regulatory specialists with informed consents and protocol amendments for investigator-initiated studies, as needed
Assists PI with implementation and maintenance of the research clinical protocol:
Oversees the protocol approval process
Maintains regulatory compliance, including oversight of IND and other regulatory work within the Program
Works with research coordinators, inpatient/outpatient nurses, research nurses, research nurse leads, research pharmacy, and other research cores to optimize the practical implementation of the Program
Ensures the proper scheduling and initiation of required research activities with sponsors of clinical trials as needed.
Ensures research staff maintain complete and accurate research data and charts in a real time basis and are well prepared for auditing and monitoring visits
Ensures SKCCC Standard Operating Procedures are in practice.
Conducts site initiation visits for studies where the PI is the Coordinating Center. Maintains communication with affiliate institutions to ensure high quality data submission, timely submission of data and adherence to guidelines.
Works with the Clinical Research Program Manager and Financial Manager to manage the process of budget generation for clinical trials in the Program
Works closely with PI and the Institution's Office of Research Billing to ensure Insurance Coverage Analyses are completed and accurate
Participates in Prospective Reimbursement Analysis meetings as needed
Works closely with the Clinical Research Program Manager to maintain a system for tracking and reporting milestones for financial invoicing within the Program
Works closely with Co-Directors of the Clinical Research Operations to anticipate the impact on resources & availability of resources for clinical trials within the Division.
Analyze resource utilization by individual trials and within programs to ensure research needs are anticipated and met
Work closely with other Clinical Research Program Managers and other Departments to help create effective, efficient research systems, and avoid duplication of effort. Work closely with Clinical Research Program Manager to ensure that Research Nurses and Data Management staff work together effectively.
Special Knowledge, Skills, or Abilities / Competencies:
Excellent organizational skills required
Excellent attention to detail skills required
Knowledge of medical terminology required
Familiar with medical procedure and laboratory fees
Ability to manage multiple and competing priorities
Knowledge of clinical research practices and principles required
Ability to understand a clinical trial financial contract
Must have excellent time management skills
Must have excellent oral and written communication skills
Ability to work in a team and demonstrated interpersonal skills
Must adhere to guidelines regarding honest reporting of sensitive and confidential patient information.
Understands the importance/impact of data integrity in terms of patients, study results, costs, quality of service and scientific research in general.
Regular contact with physicians, other health care personnel and occasionally, patients, requires the use of good judgment, tact and sensitivity.
This description is a general statement of required major duties and responsibilities performed on a regular and consistent basis by the incumbent(s).
It should not be held to exclude other duties not mentioned that are similar in nature and level of difficulty.
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline required. Minimum of five (5) years experience in the specialty or a related area required. Related master's degree may be considered in lieu of some experience, to the extent permitted by the JHU Equivalency formula. Extensive experience with clinical research sciences, regulatory affairs; Extensive experience with protocol and informed consent writing, data analysis, grant writing, and manuscript preparation and production; Prior experience managing clinical research staff required.
Master's degree strongly preferred. Seven (7) years' experience in clinical research at an academic, government, or pharmaceutical industry environment strongly preferred. Certification as a Clinical Research Professional is preferred.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Licensure, Certification, Registration:
Licensed Registered Nurse in the State of Maryland
Current CPR certification required.
Must maintain current licensure and certification during duration of employment
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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School of Medicine - East Baltimore Campus
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