Clinical Research Manager

The Department of Neurosurgery is 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, the Clinical Research Manager will 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 the 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: $57,195 - $100,040 Annually ($78,620 Targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: M-F 8:30-5
FLSA Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: NUS Pain Institute
Personnel area: School of Medicine