Clinical Research Regulatory Specialist (Radiology)

Johns Hopkins University•Baltimore, MD

4d•$49,200 - $86,200•Onsite

About The Position

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. Regulatory start-up activities include site evaluation visits, feasibility surveys, initial applications to the IRB and other regulatory agencies, and internal quality control of regulatory document management. Responsibilities also include budget and finance related issues.

Requirements

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.

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.