Summary

The Office of Surgical Research (OSR) within the Michael E. DeBakey Department of Surgery and in Collaboration with Michael E. DeBakey VA Medical Center has an immediate opening for a Clinical Research Coordinator III. This position provides with day-to-day activities and will be responsible for collecting study subject information for a clinical research study in the area of Cardiothoracic Cancer, entering research data into study database, scheduling study subjects for tests and procedures specific to the research protocol, and assisting study subjects with navigation through the study process. 

Job Duties

• Create or review research protocols and ensure adherence to regulatory requirements and scientific standards.  15%
• Submit protocols to the Institutional Review Board (IRB) for approval and maintain documentation of IRB approvals and renewals. 15%
• May help prepare budgets for clinical trials and negotiate contracts/agreements with industries, sponsors and/or research collaborators. 5%
• Obtain informed consent from participants after the principal investigator(s) identify potential participants; explain the study process and clinical visits according to the time guidelines as per study protocol. Ensure participants understand the study and address their concerns.  20%
• Collect participants’ clinical data including laboratory tests, imaging studies and follow-ups, complete case report forms (CRF) per participant accurately and enter the data into electronic databases.  15%
• Work closely with clinical staff to get informed of scheduled dates such as participant’s procedure and clinic visits.   5%
• Monitor participant safety and report adverse events to regulatory bodies. Ensure compliance with Good Clinical Practice (GCP), and study protocols. 5%
• Prepare reports for IRB and other stakeholders. 5%
• Maintain CRFs and study documents in compliance with GCP guidelines. Prepare for and participate in audits or inspections by regulatory authorities. 5%
• Serve as the point of contact between investigators, industries, and the research team under the supervision of the program director. 5%
• Interact effectively with research team members, related clinical staff, participants, and regulatory bodies. 5%

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.

Preferred Qualifications

• Bachelor’s degree in a science-related field with at least 2 years of clinical research experience.
• Master’s or medical degree may substitute with relevant clinical research experience.
• Strong experience in patient interaction is highly preferred.
• Proficient in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint).
• Excellent organizational and multitasking abilities.
• Experience with data management using electronic data capture (EDC) systems.
• ACRP or SOCRA certification is required or strongly preferred.