Clinical Research Coordinator - Psychiatry - Behavioral Med - Plassman 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:
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 non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR. Employ strategies to maintain retention rates. Evaluate 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 in person or over the phone for non-complex studies (e.g., questionnaire, data registry, scripted) or may collect information from the EHR to assist study team in determining eligibility. Develops or helps develop SOPs. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. 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. Participates in study team meetings.

Ethics:
Identifies all AEs, and determines whether or not they are reportable.  Collaborates with the PI to determine AE attributes, including relatedness to 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. Develop and submit documentation for IRB review in iRIS. Communicate with the IRB staff and reviewers and handle 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. 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.  In addition, recognizes and reports security of physical and electronic data vulnerabilities. Knowledgable about requirements for depositing data and following repository and meta-data specifications for data sharing. With guidance, locates and follows repository-specific requirements to submit study data for sharing. Knowledgeable about the use of data standards for developing research databases. (E.g. IDC 10, CDISC, MedDRA, and WHODrug). Learns and uses new technology when required. Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervison. Prepares tables, data visualizations, and lay summaries to communicate study results to participants. Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators.

Science:
Using scientific proposals from the PI, develops elements of research protocols. Demonstrates a basic understanding of the elements of research study designs. Contributes to the development of scie