MD Anderson Cancer Center Coordinator Research Data - ICT- Regulatory Team in Houston, Texas
The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
The Department of Investigational Cancer Therapeutics conducts broad phase I studies across disease boundaries and molecular targets. We strive to provide outstanding patient care while performing innovative phase I trials with new drugs that may eventually improve the management of cancer.
The primary purpose of the Coordinator, Research Data is to provide administrative and patient care services for the coordination of research studies. Coordinates and gathers patient data for research studies.
- To assist in the coordination of regulatory correspondence and protocol administration on all departmental clinical research.
– Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration).
– Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination.
– Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
– Prepare reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, semiannually, and annually for NCI studies).
– Inform sponsors and collaborators of regulatory status of protocols at least monthly in formal departmental protocol review meetings.
– Collect specimens as outlined in assigned protocols.
– Maintain a system for controlling paper flow for protocols and related grants, to include setting up and maintaining reference file system.
– Maintain and update protocol reference materials.
– Assist in the preparation of scheduled status reports describing interim data, using the Patient Data Management System.
- To assist research nurses and other clinical research personnel with patient-related activities.
– Answer and screen office phone calls effectively and professionally.
– Pick up special blood or tissue specimens correctly and in a timely fashion and transport to appropriate locations, as specified by protocols..
– Prepare tissue specimens correctly, as specified by protocols.
- Pick up special blood or tissue specimens correctly and in a timely fashion and transport to appropriate
- To transfer patient information into the electronic database and case books.
– Review medical records to extract data points.
- Assist with data entry into database and casebooks.
– Make survival calls and appropriately record the data.
– Maintain accurate and up-to-date patient flowsheet, to include entry of toxicities, adverse events, follow-up visits, dose modifications, and any other protocol-required data.
- To maintain a high level of professional expertise and credibility through educational programs, including on-site training / off-site conferences.
– Attend department research meetings and conferences.
– Attend approved off-site meetings and conferences.
– Supplement education as needed through use of reference materials, lectures, etc.
– Be punctual in arriving at all professional functions.
– Inform appropriate staff and arrange coverage for necessary functions when absent.
- To assist in the development of and help maintain an organizational system to coordinate research meetings and research deadlines and inform department staff, as needed..
– Generate documents on computer, using word processing, spreadsheet, and other software to produce professional appearance.
– Assist in the coordination and preparation of a monthly update for protocol review.
– Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.
– Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.
– Enter monitor visits for department, CTRC, Pharm into Clinic Station
Required: High school diploma or equivalent.
Preferred: Bachelor's degree in Nursing or an appropriate scientific or administrative area.
Required: Two years of related experience. May substitute required experience with completed years of college on a one to one basis.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html