Summary

The Research Coordinator II will be expected to independently coordinate day to day activities of research protocols under the general guidance of the Principal Investigator (PI) and supervising manager, which include (but are not limited to) screening, enrollment, compensation reimbursement, scheduling visits, writing and overseeing regulatory requests (i.e. IRB's, consent forms, etc.), data entry and monitoring of research participants. Ensures accurate data collection, documentation, organization and safety of research participants. This position is part of the Pediatric Cardiovascular Clinical Research Core (CVCRC) team and coordinator will work collaboratively to ensure a successful coordination of assigned clinical research projects.

Job Duties

Clinical Coordination 55%

• Interviews, screens and recruits patients for study; explains process and procedures to educate potential participants regarding the research study participation. 
• Schedules research participants for tests and procedures such as laboratory tests, x-rays, and other studies specific for the research protocol. 
• Collects patient information, organizes and maintains study records and processes documents as required by internal and external guidelines. May perform EKGs/ECG’s and obtain vital signs on study participants. Employees would receive on the job training prior to performing on study participants.
• Participates in team meetings and telephone conferencing with the sponsor/central sites.
• Collects, processes, ships, and maintains paperwork for blood, trial medication and/or biological specimens according to procedures outlined in study protocol.
• Coordinates follow-up interviews and visits with research subjects throughout study. 
• Retrieves and submits test results to appropriate party.
• Works on multiple clinical trials and sponsored research projects.
• Orders supplies and equipment. 

Data Entry/Coordination 40%

• Validates research data entered in the study database/ registry. Coordinates databases used for projects (REDCap, etc.), troubleshoots and creates new surveys for data collection.
• Uploads and retrieves results, patient notes and other relevant study information into Epic and other assigned databases. 
• Maintains and enters research data in databases/registry; conducts periodic review of data for accuracy. 
• Maintains records and regulatory documents for research studies. 

Regulatory 5%

• Writes, maintains, prepares and develops IRB protocol documents, consent forms, and regulatory documents. Ensures study data accuracy per protocol, regulatory, sponsor and BCM/TCH guidelines.
• Creates drafts in BRAIN for IRB submissions and ensures timely submission with central and local IRBs. 

Performs other job-related duties as assigned.

Minimum Qualifications

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

Preferred Qualifications and 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. 
• The ideal candidate will be self-motivated and capable of working both independently and as a member of the project team.