Job Description

Summary of Responsibilities: Acts as coordinator, and administrator of all clinical research and related duties under the guidance of clinical management and appropriate physician staff. May also act in role of Ophthalmic Technician if directed. In addition, person in this role is responsible for all technical services equipment.

Responsibilities

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.

Duties and responsibilities may be added, deleted or changed at any time at the discretion of management, formally or informally, either verbally or in writing.

Qualifications

Minimum Education Requirements:

High School Diploma.
COA, COT, or related certification.
Minimum 1 to 2 years related job experience.
College degree preferred.

Tenet Health

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