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Coordinator, Clinical Research Program- Thoracic-Head & Neck Med OncologyThe 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 2021-2022 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.MISSION STATEMENTThe mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.KEY FUNCTIONSCOMPLIANCE & QUALITY ASSURANCE & IMPROVEMENT: Coordinates and conducts departmental monitoring visits to ensure study conduct and study objectives are met Assist with quality assurance/improvement initiatives: SOP development, workflow processes, investigating root-cause analysis, assist with CAPA writing, and implement & evaluate process changes Lead the coordination and conduct departmental audits as assigned Assist in preparation of site for scheduled external audits, to include pre-audit activities to ensure readiness. Review/reevaluate databases throughout trial life to ensure build is meeting objectives of the trial. Initiate or suggest changes as necessary through quality review Performs ongoing and concurrent review of data to ensure completeness and accuracy of all trials particularly non-monitored trials and trials identified as at risk Formally prepare and report out findings of quality initiatives in group and other settings Consults and collaborates with clinical investigators at MD Anderson and other participating sites to ensure proper conduct of trials within the department of THNMO Ensure proper systems access for our multicenter participating site members Assemble protocol documentation for study activation and start-up as required per FDA regulation, sponsor standard operating procedures (SOPs), institutional and departmental standards and processes Ensures regulatory compliance with federal, state and local laws and policies related to institutional sponsored clinical research Assist in the development and maintenance of a document control system. Develop processes for organization, record, and coordination of regulatory and study-related operations Develop and maintain systems for controlling data flow; develops spreadsheets or other tracking tools for tracking overall quality of study conduct Identify and resolve problems and quality issues Track changes and updates in regulatory laws/guidelines as they occur, interpret and communicatechanges to study team members, including management. Coordinate and implement changes asnecessary Ensure consistency between protocol and related documents/tools and that the protocols arewritten in accordance with institutional and federal guidelines governing clinical research and lab protocols Collaboration with physicians and research team (i.e. nurse manager/supervisor(s), laboratory manger, supervisor clinical studies, etc.) to ensure IND exempt protocols are properly formatted, contain appropriate related documents and appendices (i.e. informed consent, abstract, etc.), are typographical or grammatical errors (investigator-initiated protocols), and feasibility criteria is met before submission to approving entities Communicates recommendations regarding patient safety and protocol inconsistencies Provides training and tools for study conduct success Generate queries for missing or incorrect data, track query return, and follow-up on all delinquent requests Performs ongoing and concurrent review of data to ensure completeness and accuracy for assigned protocols; addresses data entry omissions or inconsistencies and amend errors in a timely manner Assists in database coordination, build, and maintenance for all IIT/IND studies that are utilizing an institutional database Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually)Coordinator, Clinical Research Programs (Quality) - General DescriptionCLINICAL TRIALS COORDINATION: Consults with principal investigator and other department personnel verbally, in handwritten notes or via keyboard on computer regarding ongoing studies; requires ability to gather information and determine the appropriate information to report Participates in protocol site initiation/logistics meetings and attends departmental or institutional research meetings as well as approved off-site meetings or conferences Coordinate/communicate frequently with other research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting and protocol deviations or violations Develop templates/processes through communication with other research staff to ensure all information needed for data capture is documented Create templates for database builds, works with the PI, DMI developers, database coordinator to ensure capture of all elements to prove/disprove objectives of the study Inform research staff and others on upcoming deadlines to ensure data is completed Acts as a liaison between the research team, sponsor, CROs, other institutions, and agencies to ensure study conduct and data input are accurately and appropriately performed.ADMINISTRATIVE ACTIVITIES: Maintains a level of professional expertise and credibility through attendance at both institutional and outside continuing education programs to keep current with research changes in regulations and policy Tracks and manages all relevant protocol paperwork and essential documents in accordance with sponsor requirements and institutional policies and procedures Create and run reports on trial accrual for active protocols to assist research nurse manager and others in assigning protocols, determining workload, and initiating closure and warehousing of studies Demonstrates excellent oral and written communication skills when contacting other institutions and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, computer- generated reports/emails and/or face to face Creates, maintains, and provides status reports to departmental contracts and budgets team members to help facilitate appropriate study payment Trains staff and others on study conduct to include data management, data entry, tracking, databases, and other tasks as needed Designs, implements, and reports on projects and project statusOTHER DUTIES AS ASSIGNEDEducation 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.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.htmlAdditional Information
Requisition ID: 162543
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 53,000
Midpoint Salary: US Dollar (USD) 66,000
Maximum Salary : US Dollar (USD) 79,000
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Hybrid Onsite/Remote
Pivotal Position: No
Referral Bonus Available?: No
Relocation Assistance Available?: No
Science Jobs: Yes
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