Senior Clinical Studies Coordinator

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 2024-2025 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

The primary purpose of the Senior Clinical Studies Coordinator position is to provide independent and advanced patient care services and operational management for clinical trials.

KEY FUNCTIONS

1.       Protocol Management

·                  Assumes responsibility for the effective management/operation of research protocols in collaboration with the Principal Investigator (PI) and study sponsor.

·                  Independently performs all protocol-related tasks including accurate and successful patient screening, consenting, scheduling, retention, specimen collection, monitoring, and evaluation of patient responses.

·                  Reviews patient eligibility of potential subject cases with research nurses and physicians. Assesses patients for protocol eligibility through personal interviews and medical record review in the outpatient and inpatient settings. (may attend disease site conference or directly communicate with the PI for eligibility confirmation

·                  Reads protocol and helps develop systems for screening and scheduling patients including working with the provider/clinical team to outline a recruitment and eligibility verification plan.

·                  Assesses patients in the inpatient/outpatient clinical setting for follow up appointments per protocol requirements.

·                  Develops on-study notes and other documents as needed for protocols, including creating protocol-specific documentation reference tools.

·                  Collaborates with the multidisciplinary team as necessary.

·                  Provides documentation in the patient’s medical record or recruitment log per protocol and institutional requirements.

·                  Responsible for day-to-day regulatory management (DOA, SAE, deviations, violations, continuing review, etc.).

·                  Provides metrics to the PI including protocol overview, patient screening and retention status.

2.       Data Management and Monitoring/Audit Preparation 

·                  Responsible for protocol documentation, maintenance, quality control using paper files, electronic files, study databases and electronic data entry system.

·                  Prepares and maintains prospective patient databases for clinical research including entering relevant clinical data at designed stages in the treatment process and maintains ongoing patient files into appropriate database/s.

·                  Develops and maintains processing and tracking system for all protocol related paperwork.

·                  Assists primary investigator/s in collection and evaluation of data. Retrieves protocol-related data as documented in the medical record and accurately enters it into computerized database or on a handwritten case report form. Maintains comprehensive, accurate, up-to-date records on patients involved in studies as well as ensures records are kept in accordance with state, institutional and study guidelines. Tracks all protocols, amendments, external safety reports, continuing reviews in the study/protocol database.

·                  Compiles, maintains, and submits any relevant data as requested by the faculty to support the preparation of manuscripts, abstracts, journals, and/or posters.

·                  Prepares and generates queries and reports for protocols and provides monthly project reports to PI, managers and director.

·                  Prepares for audits and monitoring visits to ensure that all patient information is available and complete (i.e., Informed consent document, source documentation, case report forms, database report, etc.) prior to an internal or external audit. Is present at the audit for protocol questions or assistance. Will provide oversight of clinical trial protocol information that is requested for the audit by the auditor.

·                  Participates in departmental audits and collaborates with the audit team for any items that are required for an upcoming audit.

·                  Stays up to date on audit practices by participating in educational quality assurance audits within the department

3. Collaboration and Development

·                  Participates during the pre-submission stage in the clinical review of the upcoming protocols and provides feedback on any design, logistical, and clinical issues noted.

·                  Assists with developing departmental and training resources and tools as needed to include guidance with policies and procedures related to clinical trial conduct.

·                  Assists with initial and ongoing staff orientation/training and development of research personnel as needed to include group and one-on-one sessions to review protocol-specific procedures.

·                  Submits preceptee feedback to management as part of the onboarding or re-training process.

·                  Assist with cross-department biospecimen sample collection and delivery on campus.

·                  Responsible for acting as a back-up to other research coordinators in the procurement of biological sample including tissue and blood and delivery of all samples to laboratory for processing. 

·                  Ensures strict adherence to safety guidelines and use appropriate sterile techniques for obtaining samples.

·                  Collaborates with others to resolve any protocol-related lab sample inventory queries and invoice matters as needed.  

4. Institutional Compliance  

·                  Coordinates protocol development, implementation and completion to ensure regulatory compliance with federal, state and local laws and policies related to institution and department programs, with oversight from the PI, manager and/or director.

·                  Demonstrates knowledge of the research process, Code of Federal Regulations and ICH Guidelines for Good Clinical Practice. Demonstrates knowledge of the institutional reporting requirements for submission of safety reports, protocol violations and deviations.

·                  Assist with the submission of External Safety Reports to the IRB within the required timelines. Provides protocol summary reports as requested.

·                  Directly communicates and ensures approval from all the appropriate PIs and managers prior to implementation of a permanent and/or substantial work assignment change.

·                  Keep current concerning research, oncology and data management issues through reading, attending meetings and in-services

·                  Attends departmental research meetings and conferences

·                  Provides professional and ancillary staff education concerning research protocols by presenting in-services to departments as needed.

·                  Provides accurate information as requested to the multidisciplinary team

·                  Completes all mandatory institutional training requirements

Other Functions duties as assigned