Johns Hopkins University Baltimore , MD 21203
Classified Title: Research Program Manager
Working Title: Research Program Manager
Starting Salary Range: $51,975-$71,497 commensurate with experience
Employee group: Full Time
Schedule: M-F 8:30 am
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10003145-SOM Psy Geriatric Psych Neuropsychiatry
Personnel area: Johns Hopkins University
This is a senior staff level management position within the Department of Psychiatry. The responsibilities include the implementation, conduct and day to day oversight of multiple, complex neurodegenerative disease protocols, including frontotemporal lobar degeneration (FTD) and spinocerebellar ataxia (SCA). The individual is responsible for oversight of all aspects of the research projects including regulatory submissions, startup, research subject recruitment and screening, implementing study-specific procedures, site visits. The individual will represent JHU in sponsor communications as well as collaborating with faculty and staff at multiple national sites and provide training as requested by Sponsor.
This position will manage the administrative and scientific implementation of research protocols for multiple complex research studies. This position will have a great degree of independence from the PI.
The individual will ensure that all aspects of project startup are complete at JH prior to implementation, including contracts, material transfer agreements, IRB approval, delegation of authority logs, and study team training. As part of study team, the individual will collaborate with faculty, develop protocols, develop and improve SOPs, ensure SOPs are observed, develop screening forms and processes, interact with human subjects, and supervise study-related activities. The individual will oversee consent and enrollment of participants into research studies and monitoring of visits, data collection, and quality assurance checks for data completion.
This can include obtaining consent and performing the data collection or supervising staff in these procedures. The individual will perform detailed neuropsychological cognitive testing of subjects and will interview families of research participants about subject functioning and mood. The individual will perform the Scale for the Assessment and Rating of Ataxia (SARA), a standard component of the neurological exam to assess movement and speech in ataxia patients.
The individual will work with other JH departments to implement and monitor performance of study-specific protocols related to blood draws and processing, MR scanning, and lumbar puncture and cerebrospinal fluid processing. The individual will contribute to the writing of grant submissions.
This position also requires liaison with external steering committees on behalf of Hopkins regarding harmonization of multi-site study protocols and development of SOP's. The individual will also engage with advocacy groups and the care community to promote existing studies, facilitate recruitment, and disseminate study findings. The individual will also take a leading role in managing the relationship with the Sponsor and will communicate with the Sponsor regarding protocol, enrollment status and other issues related to study implementation, as well as prepare for and participate in external audits from Sponsors.
The individual is responsible for primary oversight of IRB activities, including communicating with the IRB regarding study-related concerns, and initiating and writing new applications, consent forms, changes in research, and continuing reviews. The individual is responsible for ensuring studies maintain accurate and up-to-date regulatory profiles. The individual will create and maintain regulatory binders and electronic folders with relevant current approved and required documentation.
The individual will develop and implement recruitment and retention strategies and will monitor study participant recruitment to meet objectives, including developing reports of potential participants and enrollments and collaborating with other departments and staff in and outside of JH. The position will screen potential participants to determine study eligibility.
The individual will also develop and oversee an accurate, up-to-date, and secure computer database of study participants and paper-based study files to facilitate patient encounters. The position will develop, track, and maintain storage of frozen serum specimens in computer databases and within physical storage facilities. The individual will develop and maintain cross-project monitoring systems for regulatory and major project milestone deadlines.
The individual is responsible for training staff in protocol-specific procedures including neuropsychological cognitive testing/scoring and biospecimen handling/dangerous goods shipping and for assigning and reviewing the progress of assignments. The position will involve supervising research program assistants who are responsible for the following duties: scheduling research participants, performing research protocol assessments including neuropsychological testing, entering data, and shipping biospecimens.
The individual will work closely with PIs and departmental administrators to monitor grant-related budgets. The individual will review ICTR, laboratory, radiology, and other study-related charges to ensure accuracy of bills and Sponsor invoicing and will track payments to participants.
The position will solve problems independently as needed and will communicate with the Principal Investigator, Co-Investigators and collaborators regarding the progress of the research and management of problems.
Bachelor's degree required.
5 years clinical research experience.
Demonstrated lead or supervisory responsibilities.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
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 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.
Project management experience preferred.
Special knowledge, skills, and abilities:
Clinical and neuropsychological assessments and conduct of clinical research in neuropsychiatric patients.
Experience in multi-disciplinary and multi-site collaborations and study team oversight.
Must have strong interpersonal skills to effectively interact with internal and external collaborators, study team members, study subjects, and staff.
Ability to function independently with a high degree of self-motivation and minimal supervision is essential.
Very strong organizational and problem-solving abilities and attention to detail.
Familiarity with federal, state, local, and institutional guidelines regarding conduct of research studies. Familiarity with neuropsychiatric conditions is necessary.
2 Research Program Assistants, non-employees - multiple under-graduate & graduate students.
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 firstname.lastname@example.org. 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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