Senior Clinical Studies Coordinator - Surgical Oncology

The Surgical Oncology department at MD Anderson’s Cancer Center is a multi-disease site department (specialties - Acute Care Surgical Oncology & General Surgery, Endocrine surgery, Gastric-peritoneal surface surgery, Hepatopancreatobiliary (HPB) surgery, Melanoma surgery, Sarcoma surgery), with providers who assess, plan treatment and provide surgical services to patients with goals that include improving survival, shortening recovery, maximizing quality of life and minimizing treatment-related side effects. Each specialty discipline continuously strives to better identify patients most likely to benefit from surgery, as well as to evaluate, advance and implement new cancer treatment strategies into the care of patients with solid tumors

The ideal candidate has strong experience with human subject research, clinical protocols, and patient‑facing responsibilities, and can hit the ground running with Epic, OnCore, and BIMS. They are highly organized, proactive, and capable of managing multiple time‑sensitive protocols while maintaining thorough and accurate communication. This individual must be able to complete patient screening, enrollment, study registration, and documentation with a high level of accuracy and consistency. They collaborate effectively, respond promptly to protocol needs, and contribute positively to a fast‑paced team environment.

KEY RESPONSIBILITIES 

   
Protocol Management
• Assumes responsibility for the effective operation of research protocols in collaboration with the Principal Investigator (PI) and study sponsor:
• Applies clinical and research knowledge in effective management of research protocols.
• Reviews patient eligibility of potential subject cases with research nurses and physicians. Independently performs all protocol related tasks including patient screening, consenting study subjects, collecting specimens, monitoring, and evaluating patient responses.
• Accurate and successful patient recruitment, scheduling and retention
• Reads protocol and helps develop systems for screening and scheduling patients. Develops on-study notes and other documents as needed for protocols.
• Collaborates with the multidisciplinary team as necessary
• Provides documentation in the patient’s medical record or recruitment log per protocol and institutional requirements
• Creates protocol specific documentation reference tools
• Responsible for day-to-day regulatory management (DOA, SAE, deviations, violations, continuing review, etc)

 

 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 Protocol database.
• 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.

Collaboration and Development
• Assesses patients for protocol eligibility through personal interviews and medical record review in the outpatient and inpatient settings
• Assesses patients in the inpatient/outpatient clinical setting for follow up appointments per protocol requirements
• 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.
• Participates in organization/coordination of information expected to be monitored/audited
• Assists with developing departmental and training resources and tools as needed.
• Assists with initial and ongoing staff orientation/training and development of research personnel as needed.

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