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 FMC Science, LLC Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP), and applicable federal, state, and local regulations. Supports and adheres to FMC Science 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. May administer and/or dispense investigational product and provide patient teaching regarding administration. Maintains investigational product accountability.
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.
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive amounts of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected visions and hearing to normal range.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Sufficient transportation and ability to work in multiple locations as requested.
About FMCSCIENCE, LLC
FMC Science is an independently owned and operated research site with locations in Lampasas and Georgetown. We strive to provide expert care and quality work in a caring environment. Our number one priority is the safety of our research participants.