Job Details

The Department of Neurology is seeking a Clinical Research Manager for the BIOS Clinical Trials Coordinating Center (CTCC). The BIOS CTCC manages multi-center, $30+ million federally funded clinical trials and multiple site-specific pharmaceutical-sponsored trials.

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Clinical Research Manager works 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.
• Advanced knowledge of GCP/ICH and local regulations.
• Formal project management training or certification.
• Proficiency in Microsoft Office Suite and SharePoint.

Technical Skills & Expected Level of Proficiency

• Budget Management - Advanced
• Clinical Study Design - Advanced
• Good Clinical Practices - Advanced
• Interpersonal Skills - Advanced
• Oral and Written Communications - Advanced
• Project Management - Advanced
• Record Keeping - Advanced
• Regulatory Compliance - Advanced
• Strategic Planning - Advanced

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.