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.

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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