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Banner MD Anderson Cancer Center Clinical Trials Office is the oncology service line for Banner Research. The department operates in Banner MD Anderson Cancer Center and McKee Medical Center. The department conducts Phases I-III treatment clinical trials covering all disease groups with the goal to provide support to the physician investigators and to provide trial treatment options to the patients in a safe and ethical manner, while ensuring compliance to the FDA and institutional regulations. This is M-F no weekends, no holidays!
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POSITION SUMMARY This position is responsible for coordinating and/or implementing assigned protocols. This position includes collecting and recording medical data and history, assisting in patient assessments, and maintaining study files. CORE FUNCTIONS 1. Provides study information and obtains relevant information to and from patients engaged in clinical studies, which includes: assisting in the recruitment and screening of volunteers; registering patients; providing information on clinical trials and protocols to interested participants in a timely and helpful manner; obtaining relevant medical history on candidates by phone and in person; collecting previous relevant medical records data on patient; explaining procedures and consent forms; compiling all information prior to the initial visit; responding to inquiries from study participants or collateral informants in a timely and helpful manner; updating databases with patient information; and/or, performing other related activities. 2. Performs tasks required by protocol, which may include obtaining patient medical history, systems review, phlebotomy, EKG, and cognitive assessment on patients. Collects vital signs. Maintains quality assurance on designated protocols. Collects data as required and assists in interpreting and evaluating results as required. 3. Triages adverse events and communicates with the research physician regarding the occurrence of adverse events. Collects information regarding indicated medical follow-up with the subject and collateral informants as needed. 4. Provides educational information to patients and their families. Serves as a resource and support person for patients and families by being a consistent person they can contact within the clinical research program. Provides information to the patient and family related to the healthcare of the patient such as health maintenance, prevention, and anticipatory guidance relevant to study-related diseases. 5. Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate IRB (Institutional Review Board) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process. 6. Serves as a liaison to other departments and programmatic areas, as well as community agencies. 7. Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment. 8. May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. 9. Department level responsibility. Some positions may have frequent interaction with patients, families, visitors, physicians, and related clinical departments. MINIMUM QUALIFICATIONS Must possess knowledge of clinical research methodologies as normally obtained by the completion of a Bachelors Degree in a healthcare field. Incumbents must be working towards obtaining Clinical Research Coordinator Certification (CRCC). Experience typically gained through two to four years clinical research experience. Familiarity with medical and clinical terminology. Must have excellent organizational and task management skills. Ability to maintain confidentiality of patient and study information. Ability to maintain knowledge of Federal and State regulations governing practice as well as Institute policies and procedures related to medical and nursing practice. Excellent human relations, organizational and communication skills are required. PREFERRED QUALIFICATIONS Possession of Clinical Research Coordinator Certification (CRCC). Additional related education and/or experience preferred.