Clinical Trials Specialist -- Surgery FIRST Program

Beth Israel Lahey Health

2d•$60,000 - $95,000•Onsite

About The Position

The BIDMC Surgery FIRST Program was established in 2017 to provide rigorous support for clinicians engaged in research in the Department of Surgery. The FIRST program is an expansion of the existing research support infrastructure, facilitating the use of existing resources and assisting with tasks associated with study implementation, data collection and storage, biostatistics, and regulation guiding the conduct of research with human research participants. It provides the framework to support and mentor the next generation of clinical investigators who will identify innovative solutions to existing challenges in the care of the surgical patient. The Clinical Trials Specialist is responsible for implementing; managing; and overseeing the recruiting, screening and enrolling of subjects for participation in multiple clinical trials to ensure compliance with federal, state and institutional guidelines. Financial responsibilities include preparing budgets, overseeing the grant application process and monitoring expenses for all protocols. Additional duties include overseeing the progress of protocols and planning and prioritizing the work of the Clinical Research Staff. The clinical trials specialist will primarily support clinical research and trials within the Division of Transplantation.

Requirements

Bachelor's degree required.
3-5 years related work experience required in clinical research.
Advanced skills with Microsoft applications which may include Outlook, Word, Excel, PowerPoint or Access and other web-based applications. May produce complex documents, perform analysis and maintain databases.

Nice To Haves

Prior grant management experience.
Academic degree in a scientific discipline.
Ability to converse and comprehend in a foreign language would be strongly preferred.

Responsibilities

Partners with Principal Investigator (PI) to hire, train and coach Clinical Research Staff.
Provides feedback to PI regarding annual performance evaluations of staff.
Ensures that schedules, follow-up and completion of research protocols progresses as planned.
Works with staff to resolve day-to-day problems.
Implements process of protocol for various clinical trials; coordinates sponsor conducted initiated visit(s); assists in the execution of new IRB applications and processes annual reviews for the IRB committee with regard to consents.
Collaborates with PI and/or Research Nurse in submission of protocols, amendments, notices, suspensions and terminations to the IRB for review and approval.
Attends IRB meetings as required and addresses any IRB questions regarding the protocols or consent forms.
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 Research Nurse and/or PI. Enrolls patients onto clinical trials or oversees enrollment process.
Discusses and obtains informed consent with patients.
Revises protocol consent form to comply with federal, state and IRB guidelines. Interacts with patients prior to entering the study and throughout the entire treatment.
Monitors the occurrence of adverse events and reports them according to the guidelines of the FDA, sponsoring drug accompany (if applicable) and the IRB.