Clinical Research Coordinator I (Eye Research)

Responsibilities:

• Plans and coordinates the initiation of research study protocols
• Coordinates with lab (local or central) and pharmacy as needed for
• Specimen processing
• Specimen aliquotting
• Specimen labeling
• Specimen shipping
• Maintains accurate and comprehensive records regarding clinical specimens and organizes and tracks the Eye Research sample repository
• Organize and manages IRB submission or assists in this process for new and ongoing clinical or translational studies
• Assists with patient recruitment/enrollment for clinical research studies to meet desired quotas for participants that fulfill existing eligibility criteria, obtains informed consent from patients for participation.
• Schedules clinical research-related patient appointments. Takes appropriate corrective action with patients not adhering to protocol timelines.  
• Ensures appropriate diagnostic testing has been performed per protocols, and ensures laboratory reports are reviewed by appropriate provider.
• 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 and progress reports and 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 and/or attend audits of any BEI clinical trials
• Participates in patient education initiatives regarding diabetic retinopathy and clinical trial research opportunities at the BEI/JDC, discusses clinical trial offerings with patients scheduled for regular clinic visits to maximize interest and patient enrollment
• Monitors/orders necessary supplies.
• Assists the principal investigator with various administrative tasks associated with the day-to-day operations of research studies and projects
• Works to ensure correct and timely billing of study procedures and examinations
• Serves as liaison for Dana Farber Cancer Institute, Beth Israel Deaconess Hospital and other study collaborators for patient scheduling, visit flow and study invoicing.
• Other duties as assigned.

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
• Ability to work both independently and collaboratively with other members of the lab, professional staff, and external contacts
• Demonstrate ability to follow policies and procedures mandated by Joslin Diabetes Center, HIPAA, OSHA, and the DPH.