Summary of Job:

Conducts studies in accordance with FDA regulations, following GCP guidelines. Solicits potential new studies. Develops study budgets, processes invoices to study sponsor and/or patients. Recruits, screens, schedules and retains study participants. Submits relevant and required documentation to IRB, study sponsor. Obtains informed consents. Submits required data into study-sponsor's database. Completes study sponsor's required training/certification.

Essential Duties and Responsibilities:

Solicits potential studies. Creates and submits complete proposals (including budget development, FDA forms 1572, CVs, etc.) to study sponsor and IRB. Follows FDA and GNP guidelines in doing so. Works closely with Principal Investigator (PI) on all studies. Serves as primary liaison to all study vendors (sponsors, CROS, etc.). Utilize business acumen to negotiate contracted reimbursement levels or study services in conjunction with Harvard Eye leadership. Identifies/recruits/screens/schedules potential study participants. Once patients are enrolled in a study, makes best efforts to ensure patients complete study per protocol, by proactively contacting patients to schedule required visits, etc. Submits invoices and/or payments to study sponsors/patients, ensuring payments match invoices. Manages study budget, by ensuring that actual expenses/income match budget, and identifies and resolves variances as appropriate. Informs, educates/trains ophthalmic assistants regarding data elements and tools to be utilized per study protocol. Documents training dates and attendee signatures on study-specific training log. Ensures data is collected per study protocol. Completes accurate and thorough data entry into case report forms or pre-established computer programmed formats ensuring appropriate source documentation. Ensures documentation is complete and thorough, and incorporated into complete patient medical record. Identifies and properly documents any adverse events, then communicates/coordinates with study sponsor appropriately. Maintains investigational drug/device dispensing accountability and shipping logs according to protocol guidelines. Ships specimens as required by study protocol. Meets with study sponsors and monitors as required, providing required data by required due dates. Properly closes and archives completed studies. Supports clinic as an Ophthalmic Assistant when appropriate for study related patients. Minimum Education and/or

Experience:

Successful completion of an IGH Good Clinical Practice (GCP) training program (minimum of 5 hours). Associate's or bachelor's degree in healthcare/clinical research-related field, or graduation from a clinical research education program that satisfies the criteria to apply for CCRC through ACRP preferred. Minimum of 6 months experience as a Clinical Research Coordinator, preferably in ophthalmology.

Required Certificates/Licenses:

IGH Good Clinical Practice (GCP) certification.

Required Skills/Knowledge:

Strong communication, team-member and interpersonal skills. Well-organized, with strong attention to detail. Knowledge of GCP, HIPAA and FDA statutes/regulations. Knowledge of medical and ophthalmic terminology, diseases, symptoms, medications and anatomy. Demonstrated computer literacy.

Job Type:

Full-time Pay:

$48,880.00 - $52,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Employee discount Health insurance Life insurance Paid time off Retirement plan Vision insurance

Work Location:

In person