The Clinical Research Program Manager will oversee the day to day operations of Infectious Disease Clinical Research at the Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center. Supervision of research-related staff, including research coordinators, assistants, regulatory specialists, etc. is required. In addition, the individual will be responsible for coordinating multiple research studies in ambulatory and hospitalized patients with active infectious diseases, primarily involving the areas of virus and bacterial infections, including but not limited to SARS-CoV-2, hepatitis B virus, hepatitis C virus, HIV, and co-infections with viral hepatitis and HIV. As a manager and coordinator, this individual will be responsible for maintaining regulatory compliance per Food and Drug Administration guidelines, Department of Health and Human Services guidelines, Good Clinical Practice guidelines, and ICH guidelines. Knowledge of HIPAA requirements and human subjects training is required. Requires experience working with complex clinical protocols including phase I-IV studies and protocol adherence issues.
Specific Duties & Responsibilities
Supervise and coordinate activities of research support staff; consisting of research coordinators, and Clinical Nurses; oversee day to day operations of clinical research within viral infectious diseases. Supervise research staff, coordinate multiple complex clinical trials, ensure adherence with regulatory compliance and research guidelines, and report findings to Principal Investigator
Implement, coordinate and manage multiple clinical research trials conducted within the viral infectious diseases group. This will include but is not limited to facilitating research visits with patients, conducting informed consent, reviewing laboratory results and making appropriate medication dose adjustments as per protocol, and maintaining compliance with research protocols.
Submit applications to Institutional Review Boards (WIRB and JHMIRB), GCRC and all related committees
Create and negotiate budgets with sponsor companies, assist the grants and contract analyst to invoice for research-related costs
Serve as liaison between sponsors, IRBs, multiple disciplines and the viral infectious diseases group.
Create and maintain Policy and Procedures manual for the viral infectious diseases group.
Create and implement training program for research staff.
Ensure adherence to protocols, timing and data, and study quality safety. Develop data collection instruments, protocols, organization plans and operating procedures manuals for conducting studies in collaboration with Principal Investigator.
Ensure good working relationships within center to ensure smooth operation of clinical components. Resolve issues as needed.
Develop recruitment procedures and strategies, monitor progress toward recruitment goals and prepare progress reports
Oversee data management activities including design, creation and management of study databases, data collection and editing, and compilation of data files.
Identify discrepancies using quality assurance procedures.
Conduct statistical analyses of progress and subject data, prepare reports and graphic displays; assist with manuscript preparation.
Prepare and present reports regarding status of studies, coordinate weekly viral infectious diseases group staff meetings.
RN licensure in the State of Maryland, Bachelor's degree in nursing or related discipline required. Master’s degree preferred.
Licensure, Certification, Registration:
Nurse: licensure in the State of Maryland required, phlebotomy certification preferred
Minimum of 5 years clinical research experience, experience in budget development and negotiations. Additional education may substitute for some experience, and some additional experience may substitute for some education, to the extent permitted by the JHU equivalency statement.
* 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 the 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. *
Special Knowledge, Skills, and Abilities
Excellent verbal and written communication and organizational skills required, team player, self-motivated, proficiency with Microsoft Office (Word, Excel, PowerPoint, Access), familiarity with research guidelines (GCP, ICH, HIPAA, CFR), integrity, autonomy, good supervisory skills.
Classified Title: Research Nurse Manager Working Title: CO Research Nurse Manager Role/Level/Range: ACRP/04/MG Starting Salary Range: $82,325 - $113,185; Commensurate with Experience Employee group: Full Time Schedule: Monday - Friday, 8:00am-4:30pm, 37.5 hrs/ week Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002794-SOM DOM Bay Infectious Disease Personnel area: 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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