Coordinator, Clinical Research Program - Clinical & Translational Research Center Lab

Coordinator, Clinical Research Program - Clinical & Translational Research Center Lab

MD Anderson Cancer Center

Houston, TX, United States

Title: Clinical Research Program Coordinator - CTRC Lab The primary purpose of the Clinical Research Program Coordinator position is to assist with clinical and operational management of clinical trials and provide administrative and patient care services for the coordination of those trials. Impacts research throughout the institution. Position responsibilities include but are not limited to: clinical trial coordination, implementation, quality control and monitoring of the collection, processing, storage and shipping process of laboratory samples in the CTRC laboratory. Serves as an effective point of contact regarding status and progress of Phase I and Phase II trial sample collection. Utilizes medical, laboratory, research and/or clinical knowledge to further accurate research data gathering and documentation. Requires strict adherence to federal, state, institutional and departmental guidelines, policies and procedures. Key Functions 1. Assistance with Clinical and Operational Management: · Acquires complete understanding and knowledge of the clinical protocols and develops the operation so that approved protocols and defined procedures are in compliance. · Interacts with research team and laboratory staff to assure that PK draw sheets, schedules, and lab instructions are accurate. · Coordinates CIT notification of patient treatment start and stop times and coordinates the timely response of CIT's in completing protocol mandated specimen collection, processing and as needed, shipping. · Assists in the development of lab worksheets and criteria information for assigned protocols. · Assists in protocol analysis and review for budget preparation. · Appropriately documents and provides timely notification of missed appointments and missed time points to the primary research team. · Tracks protocol related labs and research tests and assures their accurate documentation in required logs and databases. · Provides assistance upon request in the preparation of quality reports and metrics, technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals. · Collects or facilitates the collection, processing and shipment of specimens as outlined in assigned protocols upon request: a. Processes samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures. b. Performs phlebotomy, EKGs, shipments and other laboratory procedures/processes as needed to achieve trial compliance. c. Prepares and maintains database for tracking specimens with high level of accuracy. d. Serves as an information source regarding status of samples collected from patients on given protocols for PI and sponsors. · Evaluates samples for quality and condition and notes any deviations from normal in appropriate notes. · Coordinates with sponsor representative to assure consistency and maintain standard record documentation. · Manages data collection, tracking and storage. · Reports and documents clinical events. · Participates in managing expenses according to approved budget. 2. Protocol Management: · Coordinates communication of regulatory correspondence and amendments on clinical research studies. · Communicates verbally and in writing/e-mail, as needed or as requested by the principal investigator of the study with internal reviewers or external agencies (pharmaceutical companies and/or government sponsors). · Completes forms and complies with institutional, state, and federal agencies; prepares reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements. · Reviews and assures data consistency, completeness and legibility. · Attends protocol –related meetings (i.e. in-services, study start-up, site-initiation, etc.) as assigned. · Participates in protocol conference calls. · Reviews the work of a team of CIT's for compliance with regulatory and sponsor requirements and directs appropriate point of service corrections and quality edits as needed to achieve accuracy. · Conducts quality control and trial monitoring. 3. Audits and quality monitoring of data and documentation. · Maintains good-record keeping and adheres to protocol standards for records. · Prepares and coordinates audits/monitor visits for protocol compliance and data quality review. · Generates PDMS data reports, protocol summary reports, and user-generated data reports as requested. · Assures accurate documentation of all required information in the patient study folder. · Completes point of service quality of all samples of assigned CIT's. · Completes daily review of all required data into databases. · Reviews protocol documents including abstracts, text, data collection sheets, fax orders, and requisitions for relevant information. 4. Supervision and Training · Provides in-service/training to staff with regard to sample handling, processing, labeling, shipment and storage per protocol requirements. · Assist with supervision of research support staff to assure clinical protocol compliance. · Trains and orients new staff to ensure competence of duties and assignments. · Supplements the performance of phlebotomy as needed to achieve clinical trial compliance. · Prepares and maintains database for tracking specimens with high level of accuracy. · Serves as an information source regarding status of samples collected from patients on given protocols for PI and sponsors. · Facilitates the collection of collection of specimens as outlined in assigned protocols upon request 5. Other duties as assigned. Requires flexibility in work schedule due to operational requirements. Also, must be able to respond to blackberry/pager after hours/on weekends. Various meetings/work responsibilities outside of set schedule. 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. With preferred degree, one year of required experience. Hours: 9am - 5:30pm M-F 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. sonj Additional Information Employee Status: Regular Minimum Salary: US Dollar (USD) 50,800 Midpoint Salary: US Dollar (USD) 63,500 Maximum Salary : US Dollar (USD) 76,200

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Quote Reference: MD Anderson-md_anderson-4432_124479