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We are seeking a Clinical Research Manager who will work under the general supervision of a PI(s) to manage the administrative and scientific implementation of a complex clinical protocol or multiple studies and/or multiple sites. As part of a study team, collaborate with faculty, develop protocols, develop SOPs, and supervise study-related activities for one or more studies. Has accountability for grant submission and administration and regulatory compliance. 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 PI.
- Participate in scientific discussions with collaborators, PI's, and funding organizations.
- Collaborate with PI 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 PI.
- 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.
Minimum Qualifications
- Bachelor's Degree in a related field.
- Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
- Demonstrated supervisory or lead responsibilities.
- 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
- Master's Degree in a related field.
- Certification as a Clinical Research Professional.
Classified Title: Clinical Research Manager
Role/Level/Range: ACRP/04/MD
Starting Salary Range: $28.61 - $50.05 HRLY ($45,000 targeted; Commensurate w/exp.)
Employee group: Part-time
Schedule: Mon-Friday 4.5 hours per day flexible
FLSA Status: Exempt
Location: Remote
Department name: SOM DOM Infectious Disease
Personnel area: School of Medicine
