Clinical Research Coordinator
- Handles and assists with administrative and financial activities associated with the conduct of clinical trials.
- Arrange for study set-up (space, staffing, phones, computers, printers, copiers, binders, storage and other trial specific equipment).
- Acts as a liaison between site, sponsor and all related agencies.
- Handles all institutional review board documentation and correspondence; including initial submissions, protocol amendments and renewals, informed consent documents and modifications, unanticipated event reporting and serious adverse event reporting.
- Ensures compliance by coordinating all aspects of patient care to research protocols while following GCP guidelines.
- Manages research project databases, develops flow sheets and other study related documents, completes source documents and caser report forms.
- Reviews confidentiality agreements, sponsor budget templates and clinical trial agreements.
- Prepares regulatory submissions, technical progress reports and sub-contracting reports.
- Assists in completing continuation applications and study extensions.
- Develops recruitment strategies and conducts screenings for study subjects, including interviews and questionnaires.
- Reviews protocols to determine financial and resource feasibility.
- Networks with study sponsors for new studies extension.
- Maintain and upkeep of all site standard and regulatory operating procedures for research
- Monitors study procedures, scheduling of procedures and charges and coordinates other outside services as needed.
- Interfaces with research participants, determines eligibility and consents study subjects according to protocol.
- Completes and analyzes ophthalmic related diagnostic tests and requirements.
- Provide interpretation of diagnostic test results to study participants and related personnel. Keep drug accountability, randomization and subject logs.
- Obtains CPT codes and reviews billing for payments.
- Processes purchase orders, tracks deliveries; approve invoices and tracks transactions of Financial Accounting System.
- Reviews contracts and indemnification agreements from funding agencies.
- Submits requests for incremental funding, tracks payments and monitors cumulative totals.
- Supervises collection of study specimens, their processing, storage and shipping.
- Works with investigators to develop and write protocols for clinical trials and prepare supporting documents for grand and IRB approval.
- Maintains study equipment logs and calibration.
- Conducts site monitor visits and site regulatory audits.
- Acts as Ophthalmic Technician when directed, based upon needs of clinic.
- Adheres to all policies and procedures as outlined in the Employee Handbook.
- Must give 4 week notice.
- High School Diploma.
- COA, COT, or related certification.
- Minimum 1 to 2 years related job experience.
- College degree preferred.
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