Research - Laboratory/Non-Laboratory, Staff/Administrative
Responsible for operational and administrative oversight of scientific activities of a portfolio of research focused on substance use disorders, including a NIH-funded, multi-site consortium on the nexus of HIV and alcohol use disorder. Coordinate responsibilities with faculty and staff at four sites that collaborate in the NIH consortium.
Assist in finalizing research manuscripts, primarily through reference management activities.
Develop and maintain cross-project monitoring systems for regulatory and major project milestone deadlines.
Participate in the development and updating of IRB protocols and FDA INDs.
Coordinate with faculty and staff at 7 sites that collaborate in the NIH consortium.
Collaborate with faculty and other collaborators, develop protocols, and ensure protocols are observed for one or more studies.
Communicate regularly with the Principal Investigator, co-investigators and collaborators regarding the progress of the research and management of problems.
Apply independent thought to make decisions in collaboration with faculty and PIs within JHU and the NIH ARCH consortium.
Assist in the development of grant proposals, research manuscripts, preparation and execution of regulatory compliance documents.
Develop and modify resource materials and study data collection materials including study surveys, recruitment materials.
Work with the study data manager/biostatistician to develop study databases and reports.
Participate in other projects and activities as assigned.
Develop annual progress reports, oversight of regulatory compliance requirements and other activities identified by faculty or consortium members.
Track pending updates to protocols for periodic CIR submissions to the IRB.
Ensure maintenance of regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies.
Work with study investigators to develop and submit FDA INDs for new studies.
Assure protocol and study manuals have complete, consistent language throughout, including proper SAE (serious adverse event) reporting requirements, coordinating center requirements, etc.
Ensure all assigned tasks are conducted in accordance with federal regulations and ICH/GCP.
Responsible for web-site development for internal and external use.
Develop resource materials, including a quarterly newsletter.
Organize and transcribe monthly conference calls and annual working conferences of faculty and advisory members.
Bachelor’s degree in a related discipline required.
Three (3) years related experience required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 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.
Special Knowledge, Skills, and Abilities:
Ability to work independently.
Ability to interact with faculty and staff on research teams, in clinical programs, and with educational outreach initiative to strategize about their communication needs.
Excellent oral communication skills to deal effectively within and outside the department.
Excellent written communications skills in a variety of forms, print material, website content, speeches, and publicity materials.
Excellent organizational skills to work effectively in an environment that requires balancing multiple assignments.
Ability to interact effectively with individuals at all levels and from diverse cultures.
Classified title: Sr. Research Program Coordinator
Working title: Sr. Research Program Coordinator
Role/Level/Range: ACRP 37.5/E/03/MB
Starting Salary Range: $38,920.08 - $53,517.60 (commensurate with experience)
Employee group: Part-time
Employee Status: Exempt
Schedule: Monday-Friday –8:30am-5:00pm 24hrs/Wk
Location: Suite 115 - 550 N. Broadway, Baltimore, MD
Department name: 10003132-SOM Psy Alchsm and Oth Drug Dependcy Pro - Psychiatry and Behavioral Sciences
Personnel area (School): SOM – School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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