The mission of The University of Texas M. D. 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. The primary purpose of the Senior Coordinator, Clinical Studies position is to collaborate with the research team and Principal Investigator (PI) to coordinate clinical trial subject accrual and data management activities for departmental clinical research. Under the guidance of the Research Nurse Supervisor, the Senior Coordinator, Clinical Studies will also assist with the supervision of data management staff ensuring that departmental clinical research is conducted in compliance with institutional policies, the Code of Federal Regulations, and Good Clinical Practice Guidelines. **KEY FUNCTIONS** ADMINISTRATIVE  Assists with the development process of research data management staff.  Assures that policies/procedures of the institution and department are communicated to staff formally and informally by written and/or verbal means.  Participates in the development and maintenance of the staff orientation manual. Coordinates initial staff orientation and acts as lead preceptor for research clinical coordinator staff. Assesses the effectiveness of training programs, identifies learning needs, and modifies orientation process as needed. Develops and maintains templates to support staff development and increase clinical trial effectiveness.  Serves on the Clinical Research Group (CRG) Process and Policy Committee. In collaboration with the Clinical Research Group management, reviews current departmental clinical research policies and processes to ensure relevance. Modifies and/ or develops new guidelines as requested.  Assists with internal quality assurance audits of clinical research group processes related to data management and the adherence to relevant departmental policies.  Shares information and, as requested by the Research Nurse Supervisor, develops educational presentations for the monthly Clinical Research Group Meeting.  May be asked to provide coverage for key functions and/or at relevant meetings for the research team.  Manage several trials, including regional centers CLINICAL TRIAL MANAGEMENT  In consultation with the physician and research nurse, assesses patients for eligibility through personal interviews and medical record review. Responsible for accurate and successful patient recruitment to assigned protocols.  Reads protocol and in collaboration with the Research Nurse, develops systems for screening patients. Assists with the development of source document templates and other documents as needed for protocols.  In collaboration with the Principal Investigator (PI), responsible for ensuring the consent is understood, signed, and processed appropriately.  Consults with principal investigator (PI) regarding ongoing clinical trial assignments. Works closely with research nurse to ensure consistency between protocol database and source documentation; includes generating written queries for missing/deficient source documentation. As needed, obtains patient charts and outside documents required for protocol compliance.  Responsible for accurate and timely transcription of study data to paper and/or electronic Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call. Requires face-toface interaction with patients. Requires ability to gather relevant information and determine the appropriate information to report. Requires accurate and prompt patient documentation in the patient's medical record.  Knowledge of protocol databases and electronic applications; proficient in the use of Microsoft office applications and departmental electronic data systems.  Communicates routinely with intradepartmental, extramural, and industry research collaborators regarding queries, data entry, database issues, protocol status, and other events  Schedules and participates in routine monitoring. Provides sufficient, appropriate, and timely responses to sponsor queries. Participates with activities ensuring preparedness for industry, institutional, and federal clinical trial audits.  Preparation of quality reports and metrics for the purpose of grant submissions, budget creation, clinical trial evaluations, protocol review presentations, data review events, audits, conferences, posters, and manuscripts as required by the department. MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE  Attends appropriate departmental meetings and institutional continuing education programs  Plans, designs, and conducts complex professional and ancillary education sessions to ensure dissemination of new information and policies.  Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.  Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes.  Other duties as assigned. WORKING CONDITIONS This position requires: Working in Office Environment ______ No __X___ Yes Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic) __X___ No ______ Yes Exposure to human/animal blood, body fluids, or tissues _ _X __ No ______ Yes Exposure to harmful chemicals __ X __ No ______ Yes Exposure to radiation __ X __ No ______ Yes Exposure to animals __X ___ No ______ Yes PHYSICAL DEMANDS Indicate the time required to do each of the following physical demands: Time Spent Never 0% Occasionall 1-33% Frequently 34-66% Continuous ly 67-100% Standing X Walking X Sitting X Reaching X Lifting/Carrying Up to 10 lbs X 10lbs to 50 lbs X More than 50 lbs X Pushing/Pulling Up to 10 lbs X 10lbs to 50 lbs X More than 50 lbs X Use computer/keyboard X **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. 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 Additional Information + Requisition ID: 173132 + Employment Status: Full-Time + Employee Status: Regular + Work Week: Days + Minimum Salary: US Dollar (USD) 65,000 + Midpoint Salary: US Dollar (USD) 81,000 + Maximum Salary : US Dollar (USD) 97,000 + 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: No \#LI-Hybrid