Regulatory Specialist

Beth Israel Lahey Health•Boston, MA

14d

About The Position

When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. The Cortex team within the Department of Neurology at BIDMC provides world-class care and engages in clinical trials for patients with neurological disorders and conditions such as Parkinson's disease, Alzheimer's disease, Huntington’s disease, epilepsy, stroke, neuromuscular disorders, and sleep disorders. The regulatory specialist will report directly to the Cortex Program Manager and will work with faculty and study teams to support high quality and compliant conduction of clinical trials in the Department. This includes offering clinical research expertise in reviewing and implementing research protocols. Job Description: Essential 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.

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.