Clinical Research Coordinator

Job Responsibilities:

• Manage and document Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serve as the primary liaison with sponsors, IDS, and other parties as necessary.
• Prepare for and lead internal and external site visits, study monitoring, and audit visits, including providing support for the reviewer. Address and correct findings.
• Maintain participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR
• Screen participants for complex studies (e.g., procedural and interventional studies)
• Develop SOPs for specific study processes for all studies, including those complex in nature
• Coordinate, place order, collect, prepare, process, ship, and maintain the inventory of human research specimens, primarily those requiring complex procedures.
• Maintain study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
• Possess knowledge of regulatory and institutional policies and processes with ability to apply appropriately in study documentation, protocol submissions, and SOPs.
• Identify AEs, and determines whether or not they are reportable. Collaborate with the PI to determine AE attributes, including relatedness to study.
• Conduct and document consent for participants for all types of studies, including those that are complex in nature and/or require orders in Maestro Care. Develop consent plans and document for participants in a variety of studies.
• Develop and submit documentation and information for IRB review. Communicate with the IRB staff and reviewers and handle issues appropriately.
• Prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies.
• Independently respond to data queries created by a CRO or data manager. Ensure accuracy and completeness of data for all studies, including those that are complex in nature.
• Recognize data quality trends and escalate as appropriate. Develop tools for, and train others in, data quality assurance procedures.
• Recognize and report security of physical and electronic data vulnerabilities.
• Develop or review data lifecycle and management plans for multiple study protocols. Create electronic research databases and develop eCRFs and data entry SOPs according to best practices.
• Map a protocol's data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis. Innovatively use technology to enhance research studies.
• Independently use EMR and CTMS and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits.
• Provide oversight and training and lend expertise to study team. Train other team members on all aspects of study processes.

Type of Research:

This position will support the research portfolio of the Lung Transplant Program which includes industry-funded investigational drug studies, multicenter prospective observational longitudinal studies funded by the NIH, private foundations, and internally funded investigator-initiated research projects.

Special skills:

Prior research experience in the field of Pulmonary medicine, proficiency in medical terminology, EPIC, iRIS, OnCore and REDCap are preferred.