Sr. Clinical Research Coordinator

Beth Israel Lahey Health

8d•$24 - $36•Onsite

About The Position

Responsible for managing/overseeing the recruiting, screening and enrolling of patients for participation in multiple clinical trials, ensuring compliance with federal, state and institutional guidelines. Financial responsibilities including assisting with the grant application process and monitoring expenses for all protocols. Supervisory duties including overseeing the progress of protocols; supervising, planning and prioritizing the work of the Clinical Research Coordinators.

Requirements

Bachelor's degree required
1-3 years of related work experience in a medical setting; clinical research setting preferred.
Knowledge of Medical Terminology.
Working knowledge of computerized applications, including web-based applications and Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.

Nice To Haves

Master's degree preferred

Responsibilities

Participates in hiring and training Clinical Research Coordinators.
Monitors performance of staff.
Contributes to annual performance evaluations of staff.
Ensures that schedules, follow up and completion of research protocols progress as planned.
Works with staff to resolve day-to-day problems.
Assists in the execution of new IRB applications and processes annual reviews for the IRB committees with regard to consents.
May attend IRB meetings as required or address IRB questions regarding the protocols or consent forms.
Working with the principal investigator and/or research nurse, submits protocols, amendments, notices, suspensions and terminations to the IRB for review and approval.
Interacts with patients prior to entering the study and throughout the entire treatment.
Discusses and obtains informed consent with patients.
Revises protocol consent form to comply with federal, state and IRB guidelines.
Assesses potential patients' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol.
Checks all eligibility or ineligibility criteria with the patients' medical record.
Verifies information with clinical research nurse and/or principal investigator.
May enroll patients onto clinical trials.
Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB.
May interact with sponsors and/or pharmaceutical company representatives.
May prepare reports for pharmaceutical company monitors as well as routine audits for the FDA, if applicable.
Monitors strict adherence to protocols by physicians, nurses and patients.
Reviews protocol requirements with physicians, nurses and fellows.
Identifies and resolves problems with protocol compliance.
Keeps principal investigator and research nurse aware of any problems.
Prepares records for audits.
Interacts with industry or sponsoring organization representatives to review records at time of audits.
Answers queries from sponsoring organization regarding ambiguous or incomplete data.
Monitors quality and timeliness of data submissions.
Ensures data extracts completed by staff are in compliance with protocols.
May assist physician investigator in reviewing data from research protocol in order to assess efficacy of therapy and make subsequent treatment decisions.
Serves as a resource to physicians and nurses to locate information for special reports and treatment decisions.
Ensures compliance with funding agencies and assists principal investigator in the preparation of annual progress report of the grant.
May oversee the application process for grants.
Develops financial and statistical reports.
Monitors expenses related to each protocol.
May work to prepare budget.
May assist the principal investigator in obtaining new sources of funding and negotiating with prospective sponsors and collaborating institutions.
Must have full understanding and ability to explain research protocols thoroughly including goals, methods and design.
As needed, may function in areas/clinics performing job duties related to clinical research studies.