Clinical Trials Specialist — Surgery FIRST Program

Job Overview As a Clinical Trials Specialist in the Division of Transplantation at Beth Israel Lahey Health, you will implement, manage, and oversee the recruiting, screening, and enrolling of subjects for multiple clinical trials while ensuring compliance with federal, state, and institutional guidelines. You will also handle budget preparation, grant application oversight, and monitoring of protocol progress with the Clinical Research Staff. Essential Responsibilities Partner with the Principal Investigator (PI) to hire, train, and coach Clinical Research Staff. Provide feedback to PI regarding annual performance evaluations of staff. Ensure that schedules, follow‑up, and completion of research protocols progress as planned. Work with staff to resolve day‑to‑day problems. Implement protocol processes for various clinical trials; coordinate sponsor‑initiated visits; assist in the execution of new IRB applications and process annual reviews for the IRB committee regarding consents. Collaborate with PI and/or Research Nurse in submission of protocols, amendments, notices, suspensions, and terminations to the IRB for review and approval. Attend IRB meetings as required and address any IRB questions regarding the protocols or consent forms. Assess potential patients' eligibility for inclusion in a protocol based on protocols with physicians and nurses and knowledge of the protocol; verify all eligibility or ineligibility criteria with the patients' medical record and confirm with Research Nurse and/or PI. Enroll patients onto clinical trials or oversee the enrollment process. Discuss and obtain informed consent with patients; revise protocol consent form to comply with federal, state, and IRB guidelines. Interact with patients prior to entering the study and throughout the entire treatment. Monitor the occurrence of adverse events and report them according to the FDA, sponsoring drug company (if applicable), and IRB guidelines. Required Qualifications Bachelor's degree required. 3–5 years of related work experience in clinical research. Advanced skills with Microsoft applications (Outlook, Word, Excel, PowerPoint, Access) and other web‑based applications; ability to produce complex documents, perform analysis, and maintain databases. Preferred Qualifications Prior grant management experience. Academic degree in a scientific discipline. Fluency in a foreign language strongly preferred. Competencies Decision Making: make decisions guided by precedents and policies. Problem Solving: address complex, non‑recurring issues with innovative techniques. Independence of Action: set goals and determine how to accomplish results with some guidelines. Written Communications: summarize and communicate complex information in varied written formats. Oral Communications: comprehend and communicate complex verbal information in English. Knowledge: demonstrate in‑depth knowledge of concepts, practices, and policies. Teamwork: lead collaborative teams for larger projects across functional areas. Customer Service: provide high level of customer service and train staff. Physical Nature of the Job Light work: exert up to 20 pounds of force frequently to move objects; some sedentary duties, but requires standing and moving throughout the hospital campus. Pay Range $60,000.00 USD – $95,000.00 USD (annual base salary). Salary may vary based on education, experience, and other factors. Vaccination Requirement All staff must be vaccinated against influenza as a condition of employment. Equal Opportunity Employer Equal Opportunity Employer / Veterans / Disabled #J-18808-Ljbffr Beth Israel Lahey Health