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The Johns Hopkins Center for Health Equity is seeking a Research Program Manager who will deliver and organize work plans across two clinical trials and one national program office initiative. The Center works to promote equity in health for at-risk populations through advancing scientific knowledge, promoting sustainable changes in practice and policy, partnering with communities, raising public awareness of health inequities, and training scholars. Center research teams use patient and broad partner engagement and apply principles of community-based participatory research to refine and adapt intervention protocols and materials to the needs of participating organizations, clinic sites, and populations. The incumbent will work with adult community members, faculty, staff, and students from the Schools of Medicine, Nursing, and Public Health and engage with adult research participants from different backgrounds. As part of a study team, the clinical research manager will collaborate with faculty, develop protocols, develop SOPs, supervise study-related activities for one or more studies, have accountability for grant submission and administration and regulatory compliance, and supervise or oversee other exempt level research staff; may oversee staff at local or multi-center sites.
Specific Duties & Responsibilities
- Partner with investigator(s) and exercise independent judgement in managing the conduct of the research on behalf of the Pl.
- Participate in scientific discussions with collaborators, Pl's, and funding organizations.
- Collaborate with Pl to ensure operational feasibility of proposed protocol/study design.
- Develop, or oversee the development of standard operating procedures and data collection forms from protocol(s).
- Develop or oversee the development of consent form(s) for clinical trials based on protocol(s).
- Oversee preparation and submissions to IRB and act as primary liaison for regulatory compliance issues on behalf of the Pl.
- Train and provide oversight of research data management and regulatory issues.
- Work with commercial and/or government agency sponsors to determine what group can commit to considering patient population, available resources, and cost of providing services.
- Collaborate with the finance team to develop study budget(s) and ensure that all study costs are included in the budget.
- Ensure clinical research protocol has a completed Prospective Reimbursement Analysis {PRA) and processes/systems are in place to ensure the PRA is followed when required.
- Ensure adequate system for tracking and reporting clinical research milestones for financial invoicing.
- Monitor activities, systems, and processes to increase referrals and increase accruals to clinical trials.
- Ensure the development, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
- Oversee data collection at a single site or at multiple sites of a multi-centered clinical trial.
- Lead study meetings to examine data, determine next steps, implement changes to protocol operations based on results and goals, and initiate sub-studies.
- Contribute to presentations and manuscripts.
- Hire, supervise and manage performance of other exempt-level research staff.
- Other duties as assigned.
Licensure, Certification, Registration: Valid driver’s license and access to reliable vehicle.
Special Skills and knowledge
- Must be able to prioritize and coordinate multiple tasks.
- Must have the ability to work well and communicate effectively with others.
- Must have strong organizational and leadership skills and be able to work independently and as part of a team.
- Must have strong attention to detail and the ability to work with a diverse team of researchers and with diverse subject populations.
- Excellent oral and written communication skills. Experience with research protocols.
- Experience in database operations (i.e. REDCap) and/or experience in coordination of medical or laboratory research required.
- Working knowledge of PC operations and software applications such as MS Windows, Excel, Word, and Access required.
- Ability to learn new database and software applications is required. Ability to follow multiple, detailed directions of various protocols.
- Knowledge of medical terminology highly desired. Must have excellent time management skills.
Minimum Qualifications
- Bachelor's Degree in a related field.
- Five years of related experience in clinical research in an academic,
- Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
- Preferred: 5+ years of health research experience, research coordinating or managing experience, implementation research experience or experience implementing and managing large scale health initiatives; cardiovascular disease research experience.
Classified Title: Clinical Research Manager
Job Posting Title (Working Title): Research Program Manager (DOM General Internal Medicine)
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $55,800 - $97,600 Annually ($56,250 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: TBD
FLSA Status: Exempt
Location: Remote
Department name: SOM DOM General Internal Medicine
Personnel area: School of Medicine
