Clinical Research Manager

Johns Hopkins University is hiring a Clinical Research Manager for the Department of Neurology. The role supports the BIOS Clinical Trials Coordinating Center and involves organizing work plans with more than 20 clinical sites across the country. It is a full-time remote position for someone with at least five years of clinical research experience and a track record of multi-site coordination.

What you will do

• Partner with investigators and use independent judgment to manage the conduct of research on behalf of the principal investigator.
• Take part in scientific discussions with collaborators, PIs, and funding organizations.
• Work with the PI to confirm the operational feasibility of proposed protocols and study designs.
• Develop or oversee standard operating procedures and data collection forms based on protocols.
• Develop or oversee consent forms for clinical trials.
• Oversee preparation and submissions to the IRB and act as the primary liaison for regulatory compliance issues.
• Train staff and provide oversight on research data management and regulatory matters.
• Work with commercial and government sponsors to determine what the team can commit to, considering patient population, resources, and cost.
• Collaborate with the finance team to build study budgets and make sure all study costs are included.
• Ensure each protocol has a completed Prospective Reimbursement Analysis and that processes are in place to follow it.
• Maintain 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 data collection.
• Oversee data collection at a single site or across multiple sites of a multi-centered trial.
• Lead study meetings to examine data, decide next steps, adjust 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.

What they are looking for

• Bachelor's degree in a related field.
• Five years of related experience in clinical research in an academic setting.
• Strong organizational, analytical, and leadership skills, with experience in multi-site coordination.
• 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, formal project management training or certification, advanced knowledge of GCP/ICH and local regulations, and proficiency in Microsoft Office Suite and SharePoint, with the ability to learn new software such as eIRB and EDC systems.

Skills

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; additional technical skills may be required based on division or department needs.

Pay, hours, and location

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