Clinical Research Coordinator

Position: Clinical Research Coordinator

Reports to: Associate Director, Clinical Operations

Duties: Responsible for working under the guidance of the Principal Investigator and Sub-Investigators, and Clinic Operations to participate in the planning, implementation and overall direction of clinical research trials conducted on behalf of sponsors at the Frontage Clinical Services, Inc. The Clinical Research Coordinator is required to perform study procedures, to generate, evaluate, review and record study data, to transcribe source data to case report forms, to liaise with sponsor personnel, to maintain a high level of professional expertise through familiarity with the study protocol, investigator's brochure, and related study materials, and to participate in project team meetings. The Clinical Research Coordinator II assists the Principal Investigator in conducting clinical research studies in compliance with applicable regulations and GCP guidelines.

Supervises: Assistant Study Coordinators, Laboratory Technicians, and Medical Assistants

Qualifications: Requires a bachelor’s degree, preferably in a scientific discipline or equivalent experience.

Experience: A minimum of 1 year experience in clinical research is desirable. A knowledge of FDA regulatory requirements is necessary. Good communication skills with the ability to interact with the Principal Investigator, Sub-Investigators, and Frontage Clinical Research personnel and sponsor personnel.

Specific Responsibilities:

• Oversees study conduct for the assigned clinical trials.
• Assists with the preparation of protocols, informed consents, protocol amendments and other necessary documents for review by the sponsors and IRB.
• Submit documents to regulatory authorities.
• Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator.
• Maintains investigator/sponsor files in accordance with the FDA and GCP Guidelines.
• Actively involved in recruitment and in the screening activities of research subjects to evaluate their eligibility for a clinical research study.
• Actively participate in any sponsor or FDA audit.
• Develops a high level of knowledge of the study protocol and flow chart of study procedures. Develops a strategy for implementing study procedures in compliance with the study protocol.
• Understands and follows Standard Operation Procedures (SOP’s) in coordinating studies. Responsible for self-training and maintaining training records.
• Performs study procedures (e.g., start intravenous lines, venipunctures, obtain biological specimen samples, processes specimen, obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol.
• Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators.
• Records study data in Frontage eSource system and source documents. Evaluates and reviews study data to ensure accuracy and completeness.
• Assists in the reconciliation of investigational products and maintain accountability.
• Transcribes study data from source documents to sponsor designated case report forms or records data for remote data entry if applicable.
• Resolves data queries in conjunction with the sponsor.
• Assists Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
• Interacts with sponsor and Frontage senior management on subject recruitment activities, study progress updates and assists Frontage senior management with developing and tracking study budgets.
• Participates in internal/external client meetings