MD Anderson Cancer Center Sr Coord, Clinical Studies - Leukemia 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 2019 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
Protocol Management: Under supervision of the protocol primary investigator (PI) and the research nurse manager/supervisor assists the investigator in the overall conduction of the clinical trials assigned. Assesses patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings. On a real-time basis, assesses the patient's clinical status as per protocol requirements by coordinating, evaluating and following the patient's participation in clinical trials including collaborating with the entire medical care team as necessary, assisting protocol serious adverse events (SAE) reporting, participating in Quality Assurance (QA) procedure for reporting and monitoring Serious Adverse Events. Provides documentation in the patient's medical record, protocol specific documents, and institutional requirements. Communicates availability of protocol treatments for accrual. Participates in the development and maintenance of the protocol-specific documents such as dear doctor letter. Maintains the institutional patient regulatory protocol requirements (deviation logs, SAEs, AE logs, IRB continuing review, etc.). Participates in monitoring, audit activities, SIVs, conference calls, interim assessments, protocol meetings, and email/written business correspondence. Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies. Notifies clinical and/or research laboratories of protocol-required laboratory tests including EKGs, PKs, PDs, urine collection, etc. Prepare orders for protocol-related tests, procedures, consults, requests for pathology slides and blocks as needed. Communicates verbally and in writing with primary investigator, other protocol managers, clinical staff to ensure protocol patient safety and protocol compliance. Conveys information clearly, accurately and concisely through both formal and informal communication. Provides coverage for other protocol managers. Informs appropriate staff and arrange coverage for necessary functions when absent. Work in situations involving uncertainty, shifting priorities, and rapid change; deal constructively with mistakes and setbacks; demonstrate flexibility. Performing as a resources person to other protocol managers. Preceptoring and/or mentoring for new protocol managers during orientation period. Assisting in preparation of and participating in protocol audits by department, institution, sponsor or FDA.
Protocol Data: Assists the primary investigator in collection and evaluation of data. Oversees protocol-related data documentation in the medical record. Collaborates with data entry staff to ensure data is accurately entered into required database or on a handwritten case report form. Reviews patient response to treatment, treatment toxicities and adverse drug reactions with the principal investigator. Reports to the Institutional Review Board and the study sponsor. Provides protocol summary reports as requested. Participates in the departmental protocol review. Assist the primary investigator in data file preparation and participates in data review meetings as required by the department. Prepares specific protocol reports to aid decisions regarding protocol summary and to assist in manuscript preparation and presentations as necessary.
Patient Education and Professional Education: Identifies patient and family educational needs regarding treatment management, evaluation and follow-up in clinical trials through talking with patients person-to-person or by telephone and provides appropriate education and/or educational materials. Ensures human subjects protection in accordance with federal, state and institutional requirements. Facilitates the patient's provision of initial informed consent and re-consent. Addresses research participants' inquiries and concerns. Provides professional and ancillary staff education concerning research protocols by preparing in-service materials and performing protocol in-service as needed. Provides accurate information as requested to the multidisciplinary team. Keeps current concerning oncology and research study management issues through reading and or attending meetings/in-services.
Required: Bachelor's degree.
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.
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
Requisition ID: 140385
Employment Status: Full-Time
Employee Status: Regular
FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
Work Week: Days
Fund Type: Soft
Pivotal Position: No
Minimum Salary: US Dollar (USD) 59,600
Midpoint Salary: US Dollar (USD) 74,500
Maximum Salary : US Dollar (USD) 89,400
Science Jobs: No