Clinical Research Manager (Neurology)

Johns Hopkins University is hiring a Clinical Research Manager for the Department of Neurology, working with the BIOS Clinical Trials Coordinating Center. The center manages multi-center clinical trials funded by federal agencies, with budgets over $30 million, along with several site-specific trials sponsored by pharmaceutical companies. This role is for someone with at least five years of clinical research experience who has already supervised or led other research staff.

The Clinical Research Manager works under the general supervision of one or more principal investigators to manage the administrative and scientific side of a complex clinical protocol, multiple studies, or multiple sites. The position is full time, exempt, Monday through Friday, 8:30 am to 5:00 pm, and it is remote.

What you will do

• Work with investigators and use independent judgment to manage the conduct of research on behalf of the PI.
• Take part in scientific discussions with collaborators, PIs, and funding organizations.
• Work with the PI to confirm the operational feasibility of a proposed protocol or study design.
• Develop, or oversee the development of, standard operating procedures and data collection forms from protocols.
• Develop or oversee consent forms for clinical trials based on protocols.
• Oversee preparation and submissions to the IRB and act as the primary liaison for regulatory compliance issues on behalf of the PI.
• Train staff and provide oversight on research data management and regulatory matters.
• Work with commercial and government sponsors to determine which groups can commit, considering patient population, resources, and the cost of services.
• Work with the finance team to build study budgets and make sure all study costs are included.
• Make sure a clinical research protocol has a completed Prospective Reimbursement Analysis and that processes are in place to follow it when required.
• Keep a system for tracking and reporting clinical research milestones for financial invoicing.
• Monitor activities, systems, and processes to increase referrals and accruals to clinical trials.
• Oversee the development, testing, and evaluation of manuals, questionnaires, and coding structures for efficient data collection.
• Oversee data collection at a single site or across multiple sites of a multi-centered trial.
• Lead study meetings to review data, decide next steps, change protocol operations based on results and goals, and start sub-studies.
• Contribute to presentations and manuscripts.
• Hire, supervise, and manage the performance of other exempt-level research staff.
• Other duties as assigned.

What they are looking for

• 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 or equivalent, to the extent permitted by the JHU equivalency formula.

Preferred qualifications include a 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, and proficiency in Microsoft Office Suite and SharePoint.

The role expects advanced proficiency in budget management, clinical study design, Good Clinical Practices, interpersonal skills, oral and written communication, project management, record keeping, regulatory compliance, and strategic planning. The core technical skills listed are the most essential; other technical skills may be required based on division or department needs.

Pay and details

The starting salary range is $55,800 to $97,600 per year, with a target of $76,700, commensurate with experience. The classified title is Clinical Research Manager, role/level/range ACRP/04/MD. The position is full time, exempt, scheduled Monday through Friday, 8:30 am to 5:00 pm, and is remote. The department is SOM Neuro BIOS, in the School of Medicine personnel area.