Clinical Research Coordinator I (Eye Research)

Responsibilities

• Plans and coordinates the initiation of research study protocols along with the other members of the BEI clinical research team.
• Creates research applications and informed consent documents for industry-sponsored clinical studies and BEI clinical studies for IRB review/approval.
• Maintains accurate and comprehensive clinical trial records.
• Organizes and manages IRB submissions for new and ongoing clinical or translational studies.
• Organizes and manages BEI staff trial certifications.
• Assists with patient recruitment/enrollment for clinical research studies to meet desired quotas for participants that fulfill existing eligibility criteria.
• Creates and maintains organized source documents in a timely and accurate manner including (but not necessarily limited to) study enrollment logs, case report forms, and Committee of Human Studies (CHS) applications.
• Responds promptly and accurately to Protocol Queries.
• Reports serious adverse events (SAE) in a timely fashion.
• Completes assigned reports including periodic and ad hoc reports, as required by the investigator, administrators, funding agencies, and/or regulatory bodies.
• Prepares for and/or attend audits of any BEI clinical trials.
• Serves as liaison for Dana Farber Cancer Institute, Beth Israel Deaconess Hospital and other study collaborators.
• Serves as BEI Medical Retina Fellowship Coordinator.

Qualifications

• Bachelor’s degree in science area, health sciences, public health or related field
• Minimum 1 year experience conducting clinical research studies or in a medical research setting
• Previous experience involving interaction with patients or clients
• Previous experience in an ophthalmic clinical or research setting is preferred but not required
• Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professions) is preferred
• Proficient knowledge of Microsoft Office Suite
• Knowledge of electronic medical records preferred
• Understanding of ICH/GCP guidelines for human research
• Understanding of Code of Federal Regulations for Human Subject
• Strong interpersonal, organizational, and communication skills (communicate clearly and effectively via verbal and written instruction)
• Ability to speak on a one-to-one basis to engage and recruit patients, and to explain study protocols and processes
• Attention to detail and ability to concentrate on multiple tasks
• Detail oriented, with the ability to prioritize responsibilities – through completion
• Demonstrate ability to follow policies and procedures mandated by Joslin Diabetes Center, HIPAA, OSHA, and the DPH