MD Anderson Cancer Center Senior Research Data Coordinator - Surgical Oncology in Houston, Texas
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. It is one of only 49 comprehensive cancer centers designated by the National Cancer Institute.
The primary purpose of the Senior Research Data Coordinator position is to provide independent and advanced administrative and patient care services for the coordination of research studies. Acts as a lead in the development and maintenance of systems for controlling paper flow of all protocol related activities. Mentors new research data coordinators and develops an orientation plan and training schedule for new Research Data coordinators. Coordinates and schedules site initiation meetings and sponsor monitoring visits. Assists with audit preparation for both internal and external departmental audits.
ESSENTIAL JOB FUNCTIONS
Effectively conducts assigned operations of research protocols by screening for eligibility, consenting, coordinating, evaluating, and following patient participation in minimal risk trials. Performs overall coordination and organization of research projects that utilize biospecimens and clinical data. This function requires close collaboration with other departments and sponsors in order to facilitate and achieve an efficient/effective patient recruitment process. Requires close collaboration with other departments in order to facilitate and achieve an efficient/effective patient recruitment process. Maintains contact with the other institutions participating in other studies and coordinates all data. Must have the ability and willingness to receive and give clear and concise verbal and written communications. Collaborates with the primary investigators in evaluation efficacy of accrual methods and the implementation of alternative approaches. Directly communicates and ensures approval from primary investigators prior to implementation of new or existing protocols. Facilitates and coordinates the smooth flow of communication by acting as a liaison between several key players including physicians, investigators, nurses, technicians, and other personnel. Ensures research studies are properly managed as detailed in function and instructed by investigator. Schedules patient tests; keeps patient informed about test results and follow-up appointments. Tracks protocol related labs, responses, and research tests. Organizes patient calendar of tests and follow-up visits and schedules appropriate diagnostic tests and laboratory tests. Coordinates and collects blood drawing and tissue collection, processing, shipment/delivery of research specimens as required for research projects. Follow procedures for processing and storing samples. Send samples for analysis on a regular basis. Complete sample tracking logs and shipping manifests, as required. Responsible for the independent maintenance of tissue harvests and preserves fresh biological specimen collected from surgical procedures. Requests archived and prospective biological specimens from the Central Tissue Procurement Repository. Tracks all blood and tissue specimens in specialized database. Provides administrative support of the electronic data management database for the central Tissue Procurement Repository. Conducts minimal risk studies according to FDA and ICH guidelines of Good Clinical Practice. Documents and organizes protocol related items consistent with protocol guidelines, institutional and departmental policies, Good Clinical Practice and Federal Regulations. Directly communicates and ensures approval from primary investigators prior to implementation of new or existing protocols. Applies research knowledge of protocol conduct in the effective management of protocols. Screens potential patients for eligibility, obtains informed consents, registers patients in the institutional database (CORE) and thoroughly documents the informed consent process in accordance with institutional and federal guidelines. Ensures protocol and the coverage analysis are compared and all expenses have been captured. Ensures protocol order sets is completed with appropriate Research Modifiers. Ensures appropriate charge tickets are completed, submitted to the Patient Business Center (PBS) within 24 hours of service. Ensures that a protocol tracking method for payment time points is created and maintained. Responsible for obtaining, maintaining, monitoring, and ensuring safety compliance for IRB required training and safety compliance for laboratory. Orders laboratory supplies as needed for assigned protocols. Ensures strict adherence to safety guidelines and use appropriate sterile technique for obtaining samples. Walks constantly from different buildings within the institution for biological sample collection including tissue and blood and delivery of all samples to laboratory for processing
Reconciles and organizes data and records for timely submission of reports on human specimens procured. Must have the ability to communicate results, and any potential problems to the primary investigators. Responsible for review and interpretation of basic clinical data related to pathological diagnosis of patients suspected with Cancer. Responsible for completion of data forms, treatment records, surgery and pathology information. Coordinates the dissemination of data resulting from protocols for completion of data forms, treatment records and review of records to pharmaceutical companies, federal agencies, internal groups and other institutions. Demonstrates competence in key aspects of data collection and data entry incorporating institutional guidelines. Maintains comprehensive, accurate, up to date records on patients involved in studies as well as ensures records are kept in accordance with state, institutional and study guidelines. Develops and maintains system for controlling paper flow for protocols and hospital policies, including records of surgery and pathology information. Maintains department research files on all assigned patients, including the upkeep and maintenance of the regulatory binders. Develops and maintains automated processing and tracking system for all protocol related paperwork. Maintains a quality assurance system for consent documents and other protocol related activities. Maintain signed consent forms for patients enrolled in minimal risk trials. Develop system for recruiting patients, obtaining patient data, and ensuring the transfer of information to contracting agencies confidentially. Develops and maintains databases for collection of research data. Updates and maintains ongoing patient files by entering current patient survival status on datasheets, protocol case report forms and into appropriate databases. Responsible for acting as a back-up to other research data coordinators and assists research nurses with case report form completion and data query resolution. Visually reviews data for correctness and edits as necessary with RN oversight. Assists with writing abstracts, manuscripts, grants, protocols, and correspondence as necessary. Assists in preparation of information and reports for grant submission.
Audit Preparation and Monitoring Visits
Responsible for setting-up and coordinating internal and external monitor visits and site initiation meetings. Responsible for notifying in writing all relevant personnel (i.e. PIs, Supervisor Clinical Studies, Administrative Director, Protocol Research, pharmacy) of any upcoming audits and/ or monitoring visits. This includes clear and concise communication and follow-through to all relevant parties including but not limited to research nurses, INV pharmacists, CTRC staff, laboratory personnel, study monitors, regulatory personnel, research nurses and administrative director, protocol research for a successful monitor visit. Prepares for audits by ensuring that all patient information is available and complete (i.e., Informed consent document, source documentation, case report forms, photographs, etc.) prior to audit and/or monitoring visit. Responsible for completion and /or oversee completion of case report forms and data query resolution. Prepares the CRF binders and patient records for internal and external audits. Sets up audit station at least 24 hours prior to all monitoring visit and ensures that study monitors are properly vetted according to institutional guidelines.
Mentoring New Research Data Coordinator and Personnel
Serves as a preceptor and is responsible for training new research data coordinators/personnel and provides ancillary staff education on assigned research projects and clinical research policies to ensure compliance with institutional and federal guidelines. Develops an orientation plan and training schedule for new research coordinators/personnel. Meets with the new research coordinator/personnel and the Supervisor Clinical Studies on a weekly or bi-weekly schedule during the orientation period to assess the new employee's progress and to identify any areas that needs improvement. Provides feedback and recommendations to the new research coordinator/personnel and Supervisor Clinical Studies to improve/enhance learning.
Minimum: $38,000 – Midpoint: $47,500 – Maximum: $57,000
Required: High school diploma or equivalent.
Preferred: Bachelor's degree.
Required: Four 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
Employee Status: Regular
Minimum Salary: US Dollar (USD) 38,000
Midpoint Salary: US Dollar (USD) 47,500
Maximum Salary : US Dollar (USD) 57,000