Clinical Research Regulatory Specialist (Radiology)

About the role

The Department of Radiology is seeking a Clinical Research Regulatory Specialist responsible for managing regulatory issues and start-up of clinical trials, assisting with the development of investigator-initiated studies, maintaining sponsor relationships, and facilitating compliance and continuing education trainings for the specific research program.

Responsibilities

• Assist in study design in collaboration with the Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for clinical trials based on protocol(s).
• Prepare materials for submission to the IRB.
• Work with commercial and/or government agency sponsors and recommend and/or determine what group can commit to considering patient population, available resources, and cost of providing services.
• Participate in developing study budgets.
• Ensure that every clinical research protocol within the program has a completed Prospective Reimbursement Analysis (PRA), and processes/systems are in place ensuring that the PRA is followed when required.
• Assist with budget development and system for tracking and reporting clinical research milestones for financial invoicing.
• Perform self-audits and/or audit other sites.
• Identify opportunities and provide resources to facilitate needed compliance and continuing education for a program.
• Participate in study meetings and provide status updates and recommend changes to operations based on results and goals.
• Conduct literature searches to provide background information.
• Abstract and index information based on knowledge of subject matter.
• Other duties as assigned.

Qualifications

• Bachelor's Degree in a related field.
• Five years of related experience in clinical research in an academic, government, or pharmaceutical industry environment.
• Experience managing regulatory affairs.
• Experience in protocol and consent writing, data analysis, grant writing and/or manuscript preparation.
• 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.

Pay & schedule

• Starting Salary Range: $49,200 - $86,200 Annually ($70,000 targeted; Commensurate w/exp.)
• Employee group: Full Time
• Schedule: M-F 8:30-5