MD Anderson Cancer Center Coordinator, Clinical Research Program - Palliative Care & Rehab Med Research in Houston, Texas
Title: Coordinator, Clinical Research Program - Palliative Care & Rehab Med Research
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.
Maintains, provides and administrative services for the coordination of research studies for the PRIM Research Program, to include maintaining a system for controlling paper flow for protocols and hospital policies, schedules for timely submission of protocol and research data and assistance in the preparation of reports for grant and protocol submissions.
JOB SPECIFIC COMPETENCIES
Protocol and Grant Coordination
Establishes and maintains system for development of research program, including: writing, processing, submission and maintenance of protocols.
Submits retrospective and prospective studies in PDOL and follows through to IRB approval. Manages tracking system for all protocol related paperwork.
Preparing, drafting and budgeting protocols and grant submissions for the Palliative, Rehab and Integrative Medicine sections. This includes controlling paper flow for protocol submissions pertaining to research.Collects and develops criteria information for protocol submission.
Updates departmental protocol list for weekly review by Administrative Director of Protocol Research, Research Nurse Manager, and Manager Clinical Protocol Administration.
Coordinates clinical trial audits, monitors visits, and other quality assurance activities.
Clinical Research Program & Study Participant Coordination
Reviews patient eligibility/screening of potential study cases with research nurses/coordinators and faculty for assigned research studies. Coordinates, evaluates and follows patient participation in clinical trials.
Screens potential study participants and assists in obtaining consents.
Follows patients on studies, maintains documentation of participant compliance with study procedures, adverse events, and concomitant medications.
Schedules patient testing and performs procedures outlined in protocol.
Coordinates distribution of lab samples to appropriate personnel, and ships samples to outside labs.
Assists in the collection and evaluation of data.
Develops patient care methodology for protocols, including criteria for patient participation.
Coordinates randomization of patients with Biostatistics and Statistical Analyst/Database developer.
Coordinates FDA/IND audits and submissions, as well as internal audits (Clinical Research Support Center).
Develops and assists with writing and proofreading of protocols, grant proposals, abstracts and manuscripts, including grammar and proper English.
Maintains a list of abstract submission deadlines for departmental review.
Maintains schedule of timely submission of grant related reports and data.
Retrospective Studies and Data Collection Collects data for various research studies and assists with data entry for research studies.
Complies data for presentation and manuscript submission.
Prepares preliminary data for grants, reports and manuscripts.
Prepares and tabulate preliminary data for new grant submissions (tables, figures).
Preparation of consort diagrams for manuscripts including screening data, number of patients approached, eligible, and reasons for each.
Collects data for retrospective studies, including completion of data forms, treatment records, medical notes, surgery, and pathology information from ClinicStation and OneConnect.
Abstracts data from patients' medical records for retrospective studies and analysis.
Works with data team in preparing data and cleaning data for analysis.
Other duties as assigned
Analytical Thinking - Gather relevant information systematically; break down problems into simple components; make sound decisions.
Inspire Trust - Show consistency among principles, values, and behavior; gain the confidence and trust of others.
Team with Others - Initiate, develop, and manage relationships and networks; encourage collaboration and input from all team members; value the contributions of all team members; balance individual and team goals.
Written Communication - Convey information clearly and concisely through both formal and informal documents; adapt writing style to fit the audience.
Service Orientation Provide service to our customers, including patients, patient caregivers, referring physicians and each other, in a reliable, responsive, safe, friendly and courteous manner.
Education Required: Bachelor's degree.
Experience Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. .
Preferred Experience: The position would benefit from extensive knowledge of clinical trials including regulatory and auditing issues.