Summary

A research coordinator III 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 Study Coordination 40%

• Perform interviews and questionnaires of patients and families and enter the data into a RedCap databases. This will be done either in person or via zoom with follow up of all study participants.
• Obtain real-time, daily records, working with the team at the local site to collect the data for participants who are admitted into the hospital.
• Work with institutions across the world to recruit patients and obtain medical records.
• 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.
• Work on multiple studies which include clinical trials, sponsored research projects and investigator-initiated trial.
• Orders supplies and equipment.
• Perform other job duties as assigned

Data Coordination 30%

• Manages databases used for projects (REDCap, etc), may include creating new surveys for data collection, managing access, troubleshooting issues, ensuring data integrity.
• Upload and retrieve results, patient notes and other relevant study information into EPIC and other assigned databases.
• Extract data, clean data, prepare and analyze data.
• Prepare data for publication.
• Validates research data entered in the study database/ registry. 
• Maintains and enters research data in databases/registry; conducts periodic review of data for accuracy.
• Review and clean up data mid-study. File correct notes and documentation for compliance.

Regulatory 15%

• Writes, maintains, prepares and develops IRB protocol documents, consent forms, and regulatory documents.
• Ensures timely submission and approval of IRB renewals.
• Maintains records and regulatory documents for research studies.
• Ensure study data accuracy per protocol, regulatory, sponsor and BCM/TCH guidelines.

Project Coordination 15%

• Coordinate study activities among multiples teams with different scopes, which include clinical and computational teams.
• Participate and maintain scheduled meetings with the PI and co-investigators.
• Plan and implement overall study processes/activities. Document processes for use by team.
• Identify study issues, alert investigator to issues, and help problem solve.

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 with at least two years of directly related clinical research experience.
• Strong critical thinking skills with the ability to independently troubleshoot and resolve issues.
• Self-motivated and detail-oriented, with the ability to work both independently and collaboratively within a team environment.
• Experience with REDCap and EPIC systems.
• Familiarity with Institutional Review Boards (IRBs), including local and central IRBs (e.g., WIRB, Advarra).
• Experience supporting protocol development and study start-up activities.
• Working knowledge of Good Clinical Practice (GCP) guidelines and clinical trial coordination.