Summary

This position is located within IQuESt, the Center for Innovations in Quality, Effectiveness and Safety. We are the largest center for Health Services Research within the Southwest. We conduct high-quality scientific research that improves the health of patients across the nation, by helping to ensure the patient-centered delivery of scientific discoveries. We are seeking a talented individual for a full-time on-site position to join our team at Michael E. DeBakey VA Medical Center (MEDVAMC). This is a Senior Clinical Research Associate position supporting multiple sponsored projects within the Clinical Research Commons of the MEDVAMC. You will join a high-functioning clinical research team seeking to improve clinical care for our patients at the Houston VA hospital through clinical research trials. We seek a person with both regulatory and clinical trials experience, as you will be supporting new investigators as they launch clinical trials at the MEDVAMC.

The person hired into this role will serve as a research coordinator at large for clinical protocols conducted in the VA Clinical Research Commons, primarily working with new investigators who do not yet have their own research teams. Therefore, this individual should be enthusiastic, organized, detail-oriented, self-motivated, professional and able to work with minimal supervision.  Most of the projects  are nested within the Veteran’s Affairs (VA) Medical Center and involve working with VHA Regulatory requirements, IRBNet in addition to BCM IRB. Experience working with these platforms is a plus but not essential.  Ability and willingness to perform some phlebotomy (venipuncture) during study visits in the VA Clinical Research Commons is a plus.

Job Duties

• Supports daily operations for research studies and clinical trials. Recruits, screens, and enrolls study participants. 
• Collects, enters, evaluates, and tracks research data. 
• Submits documentation necessary for initial and continued IRB approval for the specific research protocol and maintains regulatory documents for research studies. 
• Interviews, screen and recruits patients for studies; explains process and procedures to educate participant regarding the research study. 
• Verifies eligibility of patients for enrollment in studies based on comprehensive inclusion and exclusion criteria outlined in the protocol. 
• Maintains study subject files. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. 
• Collects patient information through direct patient interviews, questionnaires and chart abstractions; processes documents and enter information into databases or case report forms. 
• Assesses patient data for compliance and serious adverse event reporting, and initiate expeditious reviews of study data and source documentations with the Principal Investigator as warranted.
• May perform EKGs/ECGs and obtain vital signs or other biometric information on study participants.
• May perform research related procedures as required such as venipuncture (blood draws) on study participants.
• May collect, process, ship, and maintain paperwork for blood and/or biological specimens.
• Schedules research participant for tests and procedures such as x-rays, and other studies specific for the research protocol.
• Retrieves and submit test results (such as radiology reports) to appropriate parties.
• Orders supplies and equipment as needed for specific trials.
• Trains new coordinators in clinical research procedures and regulatory compliance.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Master's degree in related field or Medical Degree.
• Experience working with clinical trials. 
• Ability to work on rare occasions evenings and/or weekends.
• Phlebotomy experience
• SOCRA certification.