The Department of Otolaryngology-HNS is seeking a full time Research Program Manager to manage the administrative and scientific implementation of our research protocol for a complex research study.
Position coordinates multiple study sites across the U.S. and leads coordination with the four laboratories involved in the study.
Manages two other study employees.
Develops the protocol and SOP, develops and leads protocol modifications, and supervises study-related activities.
Oversees ensuring the quality assurance/oversight of data collection, optimizing increasingly complex study processes and logistics (across labs, study sites and multiple staff).
Oversees compliance reporting to sponsor, MOP and research audit and reporting requirements.
Manage the administrative and scientific implementation of research protocol for complex research studies, using independent decision-making, critical thinking and analysis skills.
Act as liaison with pharmaceutical sponsors of clinical trials and act as main point of contact for individual projects.
Function as Project Manager for pathology review(s) as part of clinical trial protocols, including supervising study-related activities, developing SOPs, and training several pathologists on study protocol and ensuring that faculty are up to date with any required competencies and/or training certifications.
Communicate regularly with the Principal Investigator, co-investigators and collaborators regarding the progress of the research and management of problems.
Responsible for the recruitment, training and supervision of research personnel.
Manage the work of exempt level research staff, provide training, assign and review tasks, conduct performance appraisals, discipline/coach/counsel as appropriate.
Prepare and submit grant proposals to include National Institutes of Health grants.
Responsible for grant administration and regulatory compliance.
Prepare and update study protocols and reports for the Institutional Review Board and sponsors.
Build, manage and maintain databases, supervise data collection of clinical trial, and conduct statistical analysis of clinical data. Utilize REDCap, OpenSpecimen, SPSS, Excel, Epic, PDS software.
Responsible for requesting specimen for Taube Lab projects and for BKI principal investigators.
Collaborate with principal investigators in the Department of Dermatology, Oncology, and Bloomberg~Kimmel Institute for Cancer Immunotherapy to develop and write clinical trial protocols.
Interface with pathologists and clinicians at JHH and at outside institutions as liaison regarding clinical scenarios of specimens studied in Taube Lab.
Conduct retrospective chart review, interpret and analyze charts as appropriate.
Develop new retrospective studies to analyze tumor microenvironment in various malignancies.
Contribute to writing and submission of manuscripts.
Participate in weekly Melanoma Tumor Board meetings and monthly Melanoma Research Program meetings.
Supervise space allocation within the designated work area.
Performs miscellaneous related duties as assigned.
BA/BS degree in Biological/Social Sciences or other appropriate discipline required.
Five (5) years related experience required.
Demonstrated supervisory or lead responsibilities.
Additional education may substitute for some experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 30 undergraduate degree credits or 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 a related discipline and/or a Certification as a Clinical Research Professional is desired.
Special Knowledge, Skills, and Abilities:
Excellent reference for demonstrated strong, positive interpersonal skills
Record of ability to prioritize complex assignments and complete tasks in a timely manner
Highly organized and detail-oriented with excellent time management skills
Excellent oral and written communication skills
Ability to communicate and build relationships effectively across disciplines, settings, and cultures.
Ability to manage multiple and competing priorities.
Technical qualifications or specialized certifications:
Familiarity with prospective clinical studies or trials, research protocols, and IRB procedures
Classified title: Research Program Manager
Working title: Research Program Manager
Role/Level/Range: ACRP 37.5/E/04/MD
Starting Salary Range: $52,495 - $72,210 (commensurate with experience)
Location: 615 N Wolfe St, Baltimore, MD – East Baltimore – BSPH Location
Department name: 10003039-SOM Oto Otolaryngology Research - Otolaryngology
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 protected]. 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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