Research Data Coordinator in ICT

Required

High school diploma or equivalent. Two years of related experience. May substitute required experience with completed years of college on a one to one basis.

Preferred

Bachelor degree, good communication, data entry experience

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

Key Functions

1.   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.

–        Assemble protocol concept sheets under the direction of the study chairman or research nurse, assist in the coordination of the submission of new protocols and the revision of existing protocols, and edit informed consent forms to be protocol-specific.

–        Assist in the preparation of scheduled status reports describing interim data, using the Patient Data Management System.

–        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.

2.   To assist research nurses and other clinical research personnel with patient-related activities.

–        Answer and screen office phone calls effectively and professionally.

–        Triage patient calls to the research nursing area.

–        Work with patients to coordinate appointment schedules.

–        Relay immediately important patient messages to research nurses and other clinical research personnel.

–        Complete requests for printing of chemotherapy orders and special laboratory slips for all protocols accurately and in a timely fashion.

–        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.

–        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.

3.  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.

–        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.

4.  To maintain a high level of professional expertise and credibility through educational programs, including on-site training and 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.

–        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.

5.   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.

–        Schedule research meetings and complete all related details, including obtaining equipment, making conference room reservations, and inviting appropriate speakers and collaborators.

–        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.

6.      Other duties as assigned.