Clinical Trials Lead: Enrollment, IRB & Protocol Oversight

Beth Israel Lahey Health; Boston (MA); On-site; USD 60,000 - 95,000; Full time

Job summary

Beth Israel Lahey Health is seeking a Clinical Trials Specialist to implement, manage and oversee recruitment, screening and enrollment for multiple clinical trials, primarily within the Division of Transplantation.

The role involves budget oversight, grant applications, and monitoring expenses across protocols, ensuring compliance with federal, state and IRB guidelines while supporting staff training and protocol progress.

Qualifications

• Bachelor’s degree required.
• 3‑5 years of related work experience in clinical research.
• Advanced skills with Microsoft applications such as Outlook, Word, Excel, PowerPoint or Access and other web‑based applications.

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 protocol processes for various clinical trials; coordinates sponsor‑initiated visits; 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 (if applicable) and the IRB.

Education

Bachelor’s degree

Academic degree in a scientific discipline

Tools

Microsoft Office

Job description

Beth Israel Lahey Health is seeking a Clinical Trials Specialist to implement, manage and oversee recruitment, screening and enrollment for multiple clinical trials, primarily within the Division of Transplantation.

The role involves budget oversight, grant applications, and monitoring expenses across protocols, ensuring compliance with federal, state and IRB guidelines while supporting staff training and protocol progress.