Research Coordinator II

About the role

The Research Coordinator II will independently coordinate day to day activities of research protocols under the general guidance of the Principal Investigator (PI) and supervising manager. This position is part of the Pediatric Cardiovascular Clinical Research Core (CVCRC) team and the coordinator will work collaboratively to ensure successful coordination of assigned clinical research projects.

Responsibilities

• Screen, enroll, and recruit patients for study; explain process and procedures to educate potential participants regarding research study participation
• Schedule research participants for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol
• Collect patient information, organize and maintain study records, and process documents as required by internal and external guidelines
• Perform EKGs/ECG's and obtain vital signs on study participants (on-the-job training provided prior to performing on study participants)
• Participate in team meetings and telephone conferencing with sponsor/central sites
• Collect, process, ship, and maintain paperwork for blood, trial medication and/or biological specimens according to procedures outlined in study protocol
• Coordinate follow-up interviews and visits with research subjects throughout study
• Retrieve and submit test results to appropriate party
• Work on multiple clinical trials and sponsored research projects
• Order supplies and equipment
• Validate research data entered in the study database/registry
• Coordinate databases used for projects (REDCap, etc.), troubleshoot and create new surveys for data collection
• Upload and retrieve results, patient notes and other relevant study information into Epic and other assigned databases
• Maintain and enter research data in databases/registry; conduct periodic review of data for accuracy
• Maintain records and regulatory documents for research studies
• Write, maintain, prepare and develop IRB protocol documents, consent forms, and regulatory documents
• Ensure study data accuracy per protocol, regulatory, sponsor and BCM/TCH guidelines
• Create drafts in BRAIN for IRB submissions and ensure timely submission with central and local IRBs
• Perform other job-related duties as assigned

Qualifications

Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement. One year of relevant experience required.

Preferred Skills

• Experience with REDCap, Epic, Institutional Review Board (IRB) (local and central IRB's such as WIRB, Advarra, etc.), preparation and development
• Good Clinical Practice
• Clinical trial coordination
• Independent critical thinking and troubleshooting regarding assigned projects
• Self-motivated and capable of working both independently and as a member of the project team