Under direct supervision 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.
- Prepares for study initiation by gaining an in-depth knowledge of the protocol, developing patient recruitment plans, developing operational implementation plans for impact to care site resources
- Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients to study.
- Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and maintains investigational drug accountability. Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel. Participates in data collection, entry, and reporting for the subjects.
- In collaboration with the treating physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. May be responsible for education of clinic staff regarding clinical research.
- Participates in required training and education programs as well as monitoring and auditing activities. May work directly with sponsors. May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while on site.
- (All SCL jobs) Promotes mission, vision, and values of SCL Health, and abides by service behavior standards.
- Bachelor’s degree
- One year of experience in a clinical or scientific related discipline
- Two years of experience in a clinical or scientific related discipline and associate’s degree may be substituted for the bachelor’s degree.
- Experience in Microsoft office
- IATA Training and Certification
- Experience working with physicians
- Knowledge of FDA regulations and GCP
- Experience in electronic medical record systems, clinical trial management systems, and electronic data capture systems
Organization: St. Vincent Healthcare, Billings, MT
Primary Location: MT-Billings/Surrounding Areas-Billings
Shift: Day Shift
Job Number: 18002706