Clinical Studies Coordinator - Anesthesiology, Critical Care & Pain - Research Support

Clinical Studies Coordinator opportunity in the Anesthesiology, Critical Care & Pain - Research Support Department. 

The ideal candidate is comfortable conducting research activities in clinical environments, including the operating room (OR), and will have a bachelor’s degree and three years of experience in area of research study or direct patient care obtained from nursing, data gathering, or other related experience.  

Experience in clinical trials research in an academic, pharmaceutical, or clinical research organization (CRO) is preferred. 

Shift: Monday-Friday 8:00 am-5:00 pm typically (may vary based on research needs)

Salary range: $57,500 – minimum - $72,000 midpoint - $86,500 maximum

What’s in it for you? 

Accelerate your research career at a world-leading cancer center, gaining hands-on experience with cutting-edge clinical trials, FDA submissions, and high-impact scientific publications.

Develop advanced clinical research and patient-facing skills through collaboration with renowned investigators, multidisciplinary teams, and exposure to complex trial designs within anesthesiology, critical care, and pain.

Grow professionally in a mission-driven environment where your work directly supports MD Anderson’s goal of eliminating cancer, and where mentorship, learning opportunities, and career progression are built into the culture.

Summary
The primary purpose of the Clinical Studies Coordinator position is to provide administrative and patient care services for the coordination of clinical trials within the division.   

JOB SPECIFIC COMPETENCIES

Protocol Administration and Reporting  
• Maintains accurate study rosters, delegation logs, and documentation of staff training and qualifications.
• Collaborates with data management team, sponsors and/or regulatory team to reconcile queries, verify accuracy, and maintain clean datasets. Reviews source documents and CRFs to support accurate reporting and data integrity. 
• Prepares required study reports including enrollment logs, deviation reports, adverse event summaries, progress reports, and sponsor-requested updates
• In collaboration with the principal investigator and research supervisor, maintains essential regulatory binders and documentation (electronic and/or paper) in compliance with GCP, FDA, OHRP, and institutional standards
• Schedules and/or participates in investigator meetings, protocol training sessions, study initiation visits, and team meetings.
• Assists with study start-up and protocol preparation by reviewing and interpreting study protocols to understand objectives, eligibility criteria, procedures, and timelines as well as assists with completing and submitting study start-up documents, feasibility assessments, and regulatory packets to IRB. 
• Supports the preparation and submission of regulatory documents such as amendments, continuing reviews, and safety reports.
• Assists in preparing for internal audits, monitoring visits, and external inspections (i.e. FDA) by ensuring complete and compliant study files
• Tracks study performance metrics, provides regular updates to investigators and leadership and generates reports as requested by faculty as needed

Clinical Research Activities  
• Conducts research-related activities in clinical areas which also include operating room (OR) settings where it is required to adhere to sterile field policies, safety protocols, and OR workflow standards
• Coordinates with surgeons, anesthesiologists, nurses and technical staff to ensure research procedures are integrated smoothly into surgical workflows. 
• Maintains awareness of OR schedules, adjusts research plans as needed, and responds to rapid workflow changes as related to protocols involving the OR
• Completes data collection on case report forms (CRFs)/databases, specimen handling, timepoint tracking, and patient documentation according to protocol requirements.
• Performs protocol-mandated clinical procedures such as vital signs, processing/shipping of biological specimens per protocol requirements, administration of questionnaires, and other clinical research procedures as delegated by the Principal Investigator. 
• Reviews medical records (i.e. EPIC) to determine patient eligibility and to either obtain or assist in obtaining consents. Registers patients in Clinical Trials Management System (CTMS) and completes study documentation of study eligibility/consent process. 
• Serves as a primary point of contact for participants, providing education, answering questions, and supporting study retention.
• Identifies operational challenges and helps troubleshoot study related issues in collaboration with research and clinical team. Works with Principal Investigator and leadership to implement process improvements
• Participates in training lab activities for student interns, research assistants, residents, and/or attendings on using airway devices (or other study devices) per sponsor/manufacturer instructions
• Ensures timely reporting of adverse events, unanticipated problems, and safety updates to IRB, sponsors, and internal safety committees. 
• Schedules and accurately tracks protocol related tests and labs; coordinates with relevant testing centers and sponsor

Administrative Duties   
• Assists in the preparation and writing of research reports, manuscripts, posters and abstracts for presentation and publication
• Maintains quality control checks and a safe environment in compliance with all governmental and University policies, rules, regulation and code
• Act as a central point of contact for protocol-related questions, study document requests, and reporting timelines.  Interacts with pharmaceutical/device industry representatives 
• Assists in organizing and participating in the Texas Society of Anesthesiology Difficult Airway Workshop and the bi-annual airway training labs
• Participates in team meetings, protocol reviews, and cross-functional planning sessions to support study success; organize research staff meetings to resolve issues and prioritize activities
• Other duties as needed