About the position
The Clinical Trials Specialist at Beth Israel Deaconess Medical Center plays a crucial role in the implementation, management, and oversight of clinical trials. This position is responsible for recruiting, screening, and enrolling subjects for participation in multiple clinical trials, ensuring compliance with federal, state, and institutional guidelines. The specialist will work closely with the Principal Investigator (PI) to hire, train, and coach the Clinical Research Staff, providing feedback on their performance and ensuring that research protocols progress as planned. This role also involves resolving day-to-day problems that may arise during the clinical trial process. In addition to managing the research staff, the Clinical Trials Specialist will oversee financial responsibilities, including preparing budgets, managing the grant application process, and monitoring expenses for all protocols. The specialist will implement processes for various clinical trials, coordinate sponsor-initiated visits, and assist in the execution of new Institutional Review Board (IRB) applications. They will also be responsible for submitting protocols, amendments, and other necessary documentation to the IRB for review and approval, attending IRB meetings, and addressing any questions regarding the protocols or consent forms. The role requires assessing potential patients' eligibility for inclusion in clinical trials, verifying information with medical records, and enrolling patients onto clinical trials. The specialist will discuss and obtain informed consent from patients, revise consent forms to comply with guidelines, and monitor adverse events throughout the treatment process. This position is essential in ensuring that clinical trials are conducted ethically and effectively, contributing to the advancement of medical research and patient care.
Responsibilities
- Implement and manage the recruiting, screening, and enrolling of subjects for clinical trials.
- Partner with the Principal Investigator (PI) to hire, train, and coach Clinical Research Staff.
- Provide feedback to the PI regarding annual performance evaluations of staff.
- Ensure that schedules, follow-up, and completion of research protocols progress as planned.
- Resolve day-to-day problems with staff regarding clinical trials.
- Implement processes for various clinical trials and coordinate sponsor-initiated visits.
- Assist in the execution of new IRB applications and processes annual reviews for the IRB committee.
- Collaborate with PI and/or Research Nurse in submission of protocols, amendments, and notices to the IRB.
- Attend IRB meetings and address any questions regarding protocols or consent forms.
- Assess potential patients' eligibility for inclusion in protocols based on medical records and contracts with physicians.
- Enroll patients onto clinical trials and oversee the enrollment process.
- Discuss and obtain informed consent from patients, revising consent forms as necessary.
- Monitor the occurrence of adverse events and report them according to guidelines.
Requirements
- Bachelor's degree required.
- 3-5 years related work experience required.
- Experience in a medical setting or clinical research.
- Advanced skills with Microsoft applications including Outlook, Word, Excel, PowerPoint, or Access.
Nice-to-haves
- Prior grant management experience.
- Academic degree in a scientific discipline.
- Ability to converse and comprehend in a foreign language.
