Clinical Studies Coordinator, Radiation Oncology Clinical Research
The Clinical Studies Coordinator in Radiation Oncology Clinical Research at MD Anderson Cancer Center provides clinical evaluation, coordination, implementation and monitoring of patients enrolled in clinical research trials. This person also serves as an effective point of contact regarding status and progress of selected research trials. The Clinical Studies Coordinator impacts clinical trials patients in designated protocols; this person also utilizes medical or clinical knowledge for supervised non-clinical patient interaction for the purposes of research data gathering and monitoring. This position requires strict adherence to the policies and procedures of the institution.
Success in this position will be measured by the accuracy and timeliness of work produced, and the demonstrated ability to effectively work in a fast-paced environment. The ideal candidate will be able to anticipate needs, recognize situations requiring assistance, and have the ability to comprehend the goals of the program and take the initiative in making decisions and acting to further these goals. The ability to read, interpret, and process large quantities of printed information will be essential for this position, as well as strong verbal and written communication skills (in face-to-face encounters, by telephone, assimilating pertinent information, composing written correspondence, and understanding written and verbal directions).
The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2017 rankings.
MD Anderson is one of only 49 comprehensive cancer centers designated by the National Cancer Institute. Since 1944, more than 1.2 million patients have sought out MD Anderson's expertise. The institution pioneered a multidisciplinary approach to research-driven care. In Fiscal Year 2016, MD Anderson invested more than $787.3 million in research.
Key Functions
- Timely notification to appropriate business office that patient is on study and accurately communicate protocol endpoints and trial schema as needed.
- Confirm patients clearance to participate on trial by speaking with business center contact or reviewing business center notes in system.
- Review trial Coverage Analysis to ensure proper charges are noted during patient participation. Accurately note in EMR patient visits as appropriate to protocol schema/timeline and that research charges are accurately captured before procedures are completed.
- Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings. Identify and meet the educational, emotional, and psychosocial needs of patient and their families while participating in clinical trials.
- Coordinate, evaluate, and follow the patient’s participation in clinical settings. Collaborate with the multidisciplinary team as necessary to document patient care, achieve objectives of all assigned trials, and maintain patient safety.
- Instruct co-workers in allied fields in procedures for recording patient information.
- Maintain data necessary for audits.
- Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the Human Subject Research Manual.
- Provide support in providing coverage to protocols assigned to other research staff.
- Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
- Complete protocol and patient information needed for protocol continuing review, IND annual report, IND safety reports.
- Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.
- Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the Human Subject Research Manual.
- Review protocol documents including abstracts, text and informed consent for relevant information. Attends Study Initiation Visits and actively participates in offering protocol revisions based on anticipated workflow challenges of protocol design.
- Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in CORe per protocol. Communicate necessary registration information to sponsor company as directed by PI, and with the assistance of the research nurse.
- Gather relevant patient information related to adverse events through patient direct patient contact and or chart review.
- Schedule patient tests; keep patients informed about test results and studies.
- Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies.
- Complete case report forms in a timely and accurate fashion.
- Assist PI with completion of protocol revisions and amendments. Ensure that protocol revisions are accurately reflected in latest protocol version.
- Follow patients while on study for safety monitoring. Adhere to institutional policies concerning safety and infection control.
- Provide support for labor-intensive protocols as needed.
- Monitor protocol compliance by assisting in coordination of protocol-specific lab, radiographic, and clinical evaluation of patients.
- Act as a lead in data collection by retrieving protocol information via computer and visual chart review and by communicating directly with outlying healthcare providers to schedule and procure testing and treatment records.
- Obtain outside films, surgical, pathology and lab reports as needed per protocol and submitting specimens/films for reading.
- Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the Human Subject Research Manual.
- Retrieve protocol-related data as documented in the medical record and accurately enter it into a computerized database or on a handwritten case report form.
- Generate CORE data reports, protocol summary reports, and user-generated data reports as requested.
- Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.
- Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the Human Subject Research Manual.
- Process samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures.
- Develop and maintain database for tracking specimens with high level of accuracy.
- Serve as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.
- Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the Human Subject Research Manual.
