MD Anderson Cancer Center Senior Coordinator, Clinical Studies - Behavioral Science in Houston, Texas
Senior Coordinator, Clinical Studies - Behavioral Science
Behavioral Science provides research-driven clinical care to promote a healthy lifestyle and encourage changes to reduce cancer risk, improve adherence to cancer treatment, enhance survivors' coping with long-term consequences of cancer treatment and provide a model of optimal care for cancer-related psychosocial and behavioral issues. The model will provide a setting for translational research in cancer-related lifestyle changes and psychosocial interventions, and training for behavioral health care providers.
To conduct behavioral research on cancer risk behaviors, including the development of a behavioral sciences knowledge base; and to develop, implement, evaluate and disseminate interventions that contribute to preventing and reducing cancer incidence, mortality and morbidity.
The primary purpose of the Senior Coordinator, Clinical Studies is to implement, coordinate, and evaluate clinical trials operating in the department of Department of Behavioral Science. The Senior Coordinator, Clinical Studies hires, trains, and mentors new staff and conducts ancillary staff education sessions to ensure protocol compliance and dissemination of new information and policies. The Sr. Coordinator, Clinical Studies is responsible for protocol submissions and other regulatory activity. This individual also performs QA audits to monitor compliance and accuracy of data. Responsibilities include compiling protocol data for manuscript and grant application submission.
JOB SPECIFIC COMPETENCIES
Program Management of Clinical Trials and Research Protocols Execute protocol submissions for clinical studies and resubmissions, continuing reviews and maintain regulatory records. Review protocol documents (abstracts, text, and informed consents), initiate and implement relevant changes. Maintain and adhere to regulatory documents and policies, monitor protocol compliance and ensure protocol completion (monitor recruitment efforts) within the allotted time frame. Plan the content and direction of clinical trials (i.e., create source documents, standard operating procedures and policies, request and monitor study materials, and order study specific supplies, etc)
Evaluate and analyze data and write reports. Report registration and study completion information to sponsoring institutions. Liaison with patients, physicians, Principal Investigators, research staff and other institutions (multi-center trials) to coordinate data collection, patient care and implementation of clinical and research studies. Collaborate with the multidisciplinary team to document patient care, and the achievement of the objectives of the clinical trial. Assess patients for adverse events and follow patients while on study for safety monitoring. Adhere to institutional and federal policies concerning safety and infection control and report relevant information to sponsoring pharmaceutical companies, the institution, and grant (or funding) providers. Interact with clinic staff and department administrators to make sure research charges are documented appropriately. Conduct weekly, biweekly and monthly meetings to update Principal Investigators and sponsors regarding ongoing status of the study and status of samples collected from patients on given protocols.
Data Management Retrieve, audit and monitor protocol specific data collected, via databases, EHR and visual chart review, to confirm accuracy of data collected by all research staff. Supervise institutional and sponsor initiated audits. Monitor protocol compliance. Design and implement quality assurance procedures and policies to assure the quality of data and functionality of database. Develop and maintain database for tracking specimens with high level of accuracy.
Staff Management Supervise staff and manage personnel resources from recruitment to performance evaluations. Conducts protocol orientation for clinical trials and research studies, as well as, training of staff on policies and procedures related to the conduct of clinical trials. Plan and organize work flow and schedules. Instruct co-workers in allied fields in procedures for recording patient information.
Other duties as assigned Consent patients, register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in PDMS/CORE per institutional policy. Identify and address the educational, emotional, and psychosocial needs of patients while participating on a clinical trial. Provide support for labor-intensive protocols as needed by processing samples (label, pipette, and transfer to appropriate containers and ultimately storing specimens at specified temperatures). Orders and monitors shipping supplies for specimen transport to other labs in Houston or across states. Prepares specimens for transport and overnight delivery
Education Required: Bachelor's degree.
Experience Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.
Experience Preferred: Willing to be trained in phlebotomy, experience in behavioral interventional delivery, LPC licensed, Nursing, Mind/Body experience, Yoga instructor, Health coach, Nutrionist or certified health coach
Schedule: Monday - Friday 8am - 5pm
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