Clinical Research Coordinator

Duke Careers•Durham, NC

4d•Onsite

About The Position

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations. 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.

Requirements

Prior research experience in the field of Pulmonary medicine
Proficiency in medical terminology
Proficiency in EPIC
Proficiency in iRIS
Proficiency in OnCore
Proficiency in REDCap

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.