Clinical Trials Specialist - Cancer Clinical Trials Office
Beth Israel Deaconess Medical Center
June 27, 2018
Full Time - Experienced
Academic / Research
4 Year Degree
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.
Department Specific Job Responsibilities:
Serves as a member of the Transplant Clinical Research Program.
Works closely with the Biorepository PIs to develop and implement protocols, policies and procedures for the Transplant Institute's Biorepositories.
Develops and implements specimen collection and processing methods in collaboration with clinical and Lab Personnel to ensure integrity of specimens collected, processed, transported and stored in the manner determined by protocol. May interact with patients to collect specimens including blood, body fluid and tissue.
Coordinates with clinical and lab colleagues to collect specimens in accordance with required collection procedures developed to ensure the safe transport and proper storage of specimens in a timely manner.
Acts as committee member to direct and govern utilization of repositories and specimens therein.
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.
Bachelor's degree required.
3-5 years related work experience required.
Knowledge of medical terminology.
Strong conflict resolution and diplomatic negotiation skills.
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.
Prior grant management experience and prior experience wtih FDA and IND filings strongly preferred.
Degree in nursing with previous clinical research experience.
Phlebotomy skills a plus.
About Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center (BIDMC) is a world-class teaching hospital of Harvard Medical School located in the heart of Boston. We are passionate about caring for our patients like they are family, finding new cures, using the finest and latest technologies, and teaching and inspiring caregivers of tomorrow. We put people at the center of everything we do, because we believe in medicine that puts people first.