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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 Banner Gateway 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 role is essential for the oversight of clinical research trials, and will support the solid tumor clinical team, as well as onboarding/training new coordinators, and workload management for 3-4 disease groups.
Hours are Mon-Fri 8a-5pm, No weekends or holidays
Experience innovative technology and exceptional opportunities for growth and development at Banner Health's state-of-the-art hospital Banner Gateway Medical Center. With comprehensive electronic medical records, physician order entry, digital radiography and proprietary advanced patient monitoring, Banner Gateway provides you with the innovative resources you need to provide your patients with the best care possible. Our commitment to nursing excellence has enabled us to achieve Magnet??? recognition by the American Nurses Credentialing Center. Located near Phoenix in Gilbert, Ariz., Banner Gateway Medical Center offers 176 private rooms, eight operating suites, a 37-bed emergency department and shares a campus with the Banner MD Anderson Cancer Center. Key specialties include oncology, obstetrics, bariatric surgery, emergency and other services that focus on meeting the changing needs of the dynamic and growing community we serve. About Banner MD Anderson Cancer Center Located in Gilbert, Ariz. (the Phoenix Metro area) on the Banner Gateway Campus, the center provides world-class care for oncology patients - both inpatient and outpatient - and has also brought leading oncology programs to the Banner Gateway campus including Stem Cell Transplantation and comprehensive Head & Neck cancer care. Our capabilities include five linear accelerator vaults, a brachytherapy vault, an advanced diagnostic imaging suite with PET/CT scan, more than 50 infusion bays, a cryopreservation lab and much more. Our inpatient medical oncology unit also incorporates a program that utilizes the electronic surveillance partnership in caring for the patient, where remote nurses have the ability to interact with patients via two way audio-video to assist the bedside nurse with patient care.
POSITION SUMMARY This position provides coordination of investigational and research protocols. Coordinates operational aspects of research projects including project preparation, subject recruitment, protocol execution, data collection, and coordination and database entry.
CORE FUNCTIONS 1. Promotes research study initiation and review. Acts as the project representative and professional resource for coordination of staff, sponsors, research institutions, contract research organizations, regulatory agencies, and involved institutional departments. Reads and evaluates clinical research protocols. Attends departmental, committee, and sponsor meetings for the purpose of gathering new or revised information concerning existing or potential clinical research projects.
2. Ensures that the clinical research staff and/or students conduct the clinical aspects of the projects appropriately and adhere to the clinical trial schedule, which may include: maintaining, dispensing and recording drug and medical device supplies according to regulations; assisting in obtaining informed consent from project participants; assisting in the development and implementation of case report forms; instructing volunteers on protocol requirements and explaining procedures and consent forms; performing research patient registration; ensuring that clinical research staff conduct the clinical aspects of the projects appropriately and adhere to the schedule of the clinical trials; serving as an advocate for the research participant, assisting them through the research process; and/or, performing other related activities.
3. Develops and maintains regulatory and legal documents per guidelines and regulations of the research/study sponsor and the participating institution per IRB, FDA, PHA and other applicable regulatory agencies. Assists in annual reporting to Federal agencies as required.
4. Performs accurate data collection and reporting according to protocol requirements and completes applicable forms and/or other required reports in a timely manner. Facilitates and conducts site reviews with sponsors and other related agencies for the purpose of evaluating the accuracy and quality of the collected data. Develops and implements patient tracking and follow-up systems. Coordinates with participating physicians offices and staff for patient follow-up.
5. Assists in educating patients about research studies and in obtaining informed consent from project participants. Develops and maintains educational tools, educates research team members and assists staff in the conduct of the investigational therapy. Performs medical record reviews. Assists with patient recruitment, screening, diagnostics, treatment and education. Utilizes clinical knowledge and assessment skills necessary to evaluate, report and record accurate medical information, including responses to therapy.
6. Assists in the development and maintenance of budget and/or contract agreements. Follows policy requirements for reporting patient enrollment in an effort to ensure compliance with billing. Assists in the development of accounting reports and in coordination of billing systems.
7. Coordinates and safely implements research activities through interactions with research staff, internal and external investigators, study sponsors and Institutional Review Board (IRB).
8. Participates in the development of clinical research protocols. Performs accurate and timely data collection and reporting according to protocol requirements. Facilitates and conducts site reviews by sponsors and other related agencies for the purpose of monitoring the accuracy and quality of the collected data. May hire, train, conduct performance reviews, and direct the workflow for the department staff.
9. This position provides collaboration with various clinical and administrative positions, as well as research staff. Maintains primary facility assignment but may be asked to collaborate elsewhere either inside or outside of system. Conducts presentations to academic, professional and layperson organizations.
MINIMUM QUALIFICATIONS Must possess a thorough knowledge of nursing and healthcare as normally demonstrated through the completion of a Bachelors Degree in Nursing.
Requires a current Registered Nurse (R.N.) license. Possession of or ability to obtain a Clinical Research Coordinator Certification (CRCC) within a reasonable timeframe.
Experience typically gained through two years clinical research experience or experience related to clinical area in which research study is based. Previous relevant experience working in a clinical research setting. Knowledge of medical and clinical terminology. Excellent organizational and task management skills and the 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.
Ability to conduct computer-based literature searches is required.
PREFERRED QUALIFICATIONS Master???s Degree or advanced certificate degrees preferred.
Regulatory knowledge regarding the conduct of clinical research or health care operations is preferred.
Additional related education and/or experience preferred.
What might draw you to Banner Health? A great health care career, of course—and a great place to live, no matter what stage of life you’re in. With facilities across the West, there is a health care career for everyone, from big city living in the Phoenix area to friendly small towns in the mountains and plains. As one of the largest nonprofit health systems in the country, Banner Health offers both the stability that comes with success and the possibility of exploring new areas of the country. If you’re looking to be a key contributor to a forward-looking organization, you’ll experience a wide variety of professional advantages:
Our expansive system offers you an unmatched variety of clinical settings – from large urban trauma center to small rural hospital, ambulatory to home health.
Our commitment to healthcare innovation means you always have the latest technologies at your fingertips to help you provide the finest care possible.
The size, success and growth of our system provide you with the stability and options to pursue your desired career path.
Competitive compensation and comprehensive benefits offer you options to complement your unique needs.