The Neuro-Oncology department provides state-of-the-art treatment for patients with cancers of the brain and nervous system. Physicians in the department also provide expert care for patients with neurologic complications from cancer or cancer therapies. By translating laboratory findings into new treatments, MD Anderson's Neuro-Oncology department offers more effective therapies, improved survival rates and quality of life for brain tumor patients. \n \nThe idea candidate will have 1-2 years of experience with patient and / or clinical trials. Neuro experience preferred. The schedule is Monday - Friday, 8am-5pm. \n \nThe primary purpose of the Coordinator, Clinical Studies is to provide clinical evaluation, coordination, implementation, and monitoring of patients enrolled in phase I research protocols. Also serves as an effective point of contact regarding status and progress of phase I trials. Impacts clinical trials patients in designated protocols. Utilizes medical or clinical knowledge for supervised non-clinical patient interaction for the purposes of research data gathering and monitoring. Requires strict adherence to the policies and procedures of the institution.\n \nKEY FUNCTIONS \n \nProtocol Management \n \nCoordination of activities related to initiation and conduct of clinical trials: \n \nWork with staff in Patient Business Services to develop research charge tickets for protocols. \n \nInteract with clinic staff to make sure research charge tickets are used appropriately and that billing to sponsored study accounts is accurate. \n \nTimely notification of patient on study to patient access coordinator and PBS. \n \nScreen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings. Identify and meet the educational, emotional, and psychosocial needs of patient and their families while on clinical trials. \n \nCoordinate, evaluate, and follow the patient's participation in clinical settings. Collaborate with the multidisciplinary team as necessary to document patient care, achieve objectives of trials, and maintain patient safety. \n \nInstruct co-workers in allied fields in procedures for recording patient information. \n \nMaintain data necessary for audits. \n \nUnderstand 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.\n \nCoordination of regulatory correspondence on clinical research studies: \n \nCommunicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors). \n \nComplete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.\n \nDirect support to clinical trial research protocols: \n \nReview protocol documents including abstracts, text and informed consent for relevant information. \n \nRegister patients on research protocols by verifying eligibility/exclusion criteria and entering patients per protocol. Communicate necessary registration information to sponsoring drug company as directed by PI, and with the assistance of the research nurse. \n \nSchedule patient tests; keep patients informed about test results and studies. \n \nAssist in obtaining consent for studies. \n \nAct as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies. \n \nComplete case report forms in a timely and accurate fashion. \n \nAssist in the screening for adverse events. \n \nAssist in modifying consents; submit to IRB. \n \nFollow patients while on study for safety monitoring. Adhere to institutional policies concerning safety and infection control. \n \nProvide support for labor-intensive protocols as needed. \n \nMonitor protocol compliance by assisting in coordination of protocol-specific lab, radiographic, and clinical evaluation of patients. \n \nAct as a lead in data collection by retrieving protocol information via computer and visual chart review and by communicating directly with outlying healthcare providers to schedule and procure testing and treatment records. \n \nObtain outside films, surgical, pathology and lab reports as needed per protocol and submitting specimens/films for reading.\n \nData participation\n \nAssist the primary investigator in collection and evaluation of data: \n \nRetrieve protocol-related data as documented in the medical record and accurately enter it into a computerized database or on a handwritten case report form. \n \nGenerate OnCore data reports, protocol summary reports, and user-generated data reports as requested. \n \nProvide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.\n \nCollect or facilitate the collection of specimens as outlined in assigned protocols upon request: \n \nProcess samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures. \n \nDevelop and maintain database for tracking specimens with high level of accuracy. \n \nServe as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.\n \nMD Anderson offers our employees: \n\n Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week.\n Group Dental, Vision, Life, AD&D and Disability coverage.\n Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals.\n Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs.\n Tuition Assistance Program after six months of service.\n Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans.\n Employer paid life, AD&D and an illness-related reduced salary pay program.\n Extensive wellness, recognition, fitness, employee health programs and employee resource groups. \n Opportunities for professional growth through Career Development Center and Mentoring programs.\n \nEDUCATION\n\n Required: Bachelor's Degree\n Preferred: Master's Degree Public Health or related scientific field.\n \nWORK EXPERIENCE\n\n Required: 3 years Research study or direct patient care experience obtained from nursing, data gathering or other related experience; With preferred degree, 1 year required experience. \n May substitute required education degree with additional years of equivalent experience on a one to one basis.\n \nThe University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.\n \nThis position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.\n \nIt 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\n \nAdditional Information \n\n Requisition ID: 176742 \n Employment Status: Full-Time \n Employee Status: Regular \n Work Week: Days \n Minimum Salary: US Dollar (USD) 57,500 \n Midpoint Salary: US Dollar (USD) 72,000 \n Maximum Salary : US Dollar (USD) 86,500 \n FLSA: non-exempt and eligible for overtime pay \n Fund Type: Soft \n Work Location: Onsite \n Pivotal Position: No \n Referral Bonus Available?: No \n Relocation Assistance Available?: No \n \n#LI-Onsite