Clinical Research Coordinator - Psychiatry - Child Division - Conradt Lab

School of Medicine

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Operations:

• Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes.
• Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others.
• Maintains 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. May train or oversee others.
• Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others.
• Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others.
• Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others.
• Develops or helps develop SOPs. May train or oversee others.
• Maintains study-level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others.
• Conducts activities for study visits in compliance with the protocol. May train staff.
• Leads effective facilitation of team meetings to achieve objectives. Ensures good communication across multiple study teams and mentors staff to improve communication strategies.

Ethics:

• Identifies all AEs and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to the study. May train or oversee others.
• Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. May train or oversee others.
• Develops consent plans and documents for participants in a variety of studies. May train or oversee others.
• Develops and submits documentation and information for IRB review. Communicates with IRB staff and reviewers and handles issues appropriately. May train or oversee others.
• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:

• Enters and collects data. Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data.
• Assists with quality control and data cleaning as directed. Independently responds to queries created by a CRO or the data manager. Independently corrects and documents incomplete, inaccurate, or missing data for non-complex studies. Follows SOPs for quality assurance.
• Runs summaries and reports on existing data. Follows required processes, policies, and systems to ensure data security and provenance. Learns and uses new technology when required.
• Develops reports on study progress for the PI and other study team members and collaborators. Creates