Clinical Research Coordinator
207 West Avenue E, Downstairs Lampasas, TX 76550 US
Clinical Research Coordinator
Under minimal supervision of a physician and nurse (if applicable), is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials. Collaborates with physician in determining eligibility of patients for clinical trials. Provides education to staff and patients. Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP), and applicable federal, state, and local regulations. Supports and adheres to company Code of Ethics Business Standards.
Essential Duties and Responsibilities:
• Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients,
participates in the informed consent process and enrolls patients on protocol.
• Coordinates patient care in compliance with protocol requirements.
• Maintains investigational product accountability. May administer and/or dispense investigational product and provide patient teaching regarding administration.
• In collaboration with the investigator, reviews patients for changes in conditions, adverse events, concomitant medication use, and protocol compliance and thoroughly documents all findings.
• Responsible for accurate and timely data collection, documentation, entry, and reporting.
• Reports safety data in accordance with sponsor and IRB timelines.
• Works with sponsor representatives during site initiation visits, interim monitoring visits, etc.
• Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
• Identifies quality and performance improvement opportunities and collaborates with staff in development of action plans to improve quality.
• Works closely with Recruitment Director to identify appropriate patients for clinical trials
• Responsible for local management of assigned research studies from start-up to study close-out
• Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Associates degree in a clinical or scientific related discipline required, Bachelor’s degree preferred. Minimum of two years experience in a clinical or scientific related discipline, preferably in clinical research. SoCRA or ACRP certification preferred. Must be knowledgeable of FDA Guidance in Clinical Research and ICH/GCP Guidelines. Must have excellent written and verbal communication skills, a strong background in medical/clinical terminology and medications, and be proficient in Microsoft Office applications.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.