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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 2022-2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.The 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.KEY FUNCTIONSData Management· Assists the principal investigator in collection and evaluation of clinical research data· Abstracts and collects patient data from electronic health record and other relevant source documents· Enters research study data into paper or electronic case report forms (CRFs) or local data systems as required, in accordance with protocol requirements and departmental timelines· Performs ongoing and concurrent review of data to ensure completeness and accuracy· Addresses data entry omissions or inconsistencies and amends errors in a timely manner· Maintains and updates database for protocols, related grants and protocol reference materials· Prepares scheduled status reports and assists with data analysis, as needed· Provides data for study progress and patient safety reports, such as IRB continuing reviews and IND reports· Monitors and records in relevant systems outside laboratory data for protocol patients; processes same to ensure PI and research nurse are notified in a timely fashion· Follows and adheres to department and sponsor guidelines to accomplish and complete daily workProtocol Management· Under supervision of the principal investigator (PI) and research data supervisor/manager assists the investigator in the overall conduction of assigned clinical trials· Participates in Site Initiation Visits (SIVs), conference calls and protocol meetings· Ensures the conduction of assigned clinical trials is in accordance with Good Clinical Practice guidelines, federal regulations, institutional and departmental policies and procedures.· Tracks and manages all relevant protocol paperwork and essential documents in accordance with sponsor requirements and institutional policies and procedures· Tracks protocol-required patient labs, tests, visits, and procedures through the electronic health record· Maintains knowledge of and assists in recording adverse events· Collaborates in section or departmental protocol review on design, budgeting and planning aspects· Creates, maintains, and provides status reports to departmental contracts and budgets team members to help facilitate appropriate study payment· Provide coverage for other coordinators and informs appropriate staff and arrange coverage for necessary functions when absent· Schedules internal and external auditor/monitor visits for a team, section or department· Schedules/reschedules protocol-related research lab visits in Epic or current scheduling system· Conducts pill counts and completes drug accountability reports for assigned studies related to disposition of unused/returned study drugClinical Trials Coordination· Consults with principal investigator and other department personnel verbally, in handwritten notes or via keyboard on computer regarding ongoing studies· Communicates effectively both verbally and in writing, with internal reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration)· Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually).· Coordinates with 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· Coordinates and participates in monitoring visits and internal or external audits to ensure objectives are met· Applies knowledge and experience when addressing study issues, gathering relevant information systematically and making sound decisions· Acts as a liaison with research team, caregivers, patients as well as other institutions and agencies and initiates, develops, and manages these relationships and networks· Works in situations involving uncertainty, shifting priorities and rapid change dealing constructively with mistakes and setbacks and demonstrating flexibility· Participates in the orientation or continuing training of other research staff, as needed· Assists with responsibilities and activities within the coordinators' office in accordance with individual strengths and expertise· Maintains a high level of professional expertise and credibility through educational programs, including on-site training and off-site conferences· Leads small group discussions and holds educational sessions for research data coordinator staff concerning clinical research protocols, regulations and best practices as neededOther duties as assignedEDUCATIONRequired: High school diploma or equivalent.Preferred: Bachelor's degree.EXPERIENCERequired: Four years of related experience. With preferred degree, no experience required.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: 164811
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 41,500
Midpoint Salary: US Dollar (USD) 52,000
Maximum Salary : US Dollar (USD) 62,500
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: No
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