Position Summary:
Under limited supervision, coordinates Research Coordinator (RC) Program activity, including clinical trial
regulatory affairs and clinical trial and research data coordination.
Essential Functions:
Prepares regulatory documents and monitors regulatory activities for assigned clinical trials.
Prepares protocol for initial and continuing Institutional Review Board (IRB) review; submits protocol
revisions and amendments for IRB review; submits Serious Adverse Events reports and
Investigational Drug Safety Reports to the IRB; maintains IRB correspondence documentation for
study sponsor and cooperative group audits. Prepares initial Informed Patient Consent forms for
study participation; prepares form revisions when requested by study sponsor and submits for IRB
review. Prepares regulatory documentation binders for study monitoring and audits by National
Cooperative Groups (NCG)/Pharmaceutical and Device companies/FDA; assists in preparation of
patient charts for audits and monitoring visits; assists in the management of clinical trial data.



High School Diploma/GED equivalent

Additional Information
For more than a decade, LifeBridge Health's focus has been to partner with others who provide high-quality health care services. Through these partnerships, patients who choose a physician affiliated with LifeBridge Health have convenient, coordinated access to almost anything they need for their health. Today more than 1,700 physicians are affiliated with LifeBridge Health. About 500 of them are members of the LifeBridge Physician Network (LBPN), a voluntary physician-governed association. The LBPN is creating a more integrated care system so that patients receive higher quality care that better fits their needs.

LifeBridge Health is an Equal Opportunity Employer.

If you are interested in applying for employment and require accommodation during any part of the application process, please call 410-601-9000 and ask to speak to the Human Resources Department at the location to which you are applying. For TTY users, please call via Maryland Relay.