CLINICAL RESEARCH COORDINATOR

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.

 

Be You. 

 

Duke University’s Department of Obstetrics and Gynecology has an immediate on – site position supporting multiple research studies in the Gynecologic Oncology division, conducted by multiple investigators. This portfolio only includes non-treatment oncology trials. Duties will include screening for research studies, obtaining written consent, conducting study visits, maintaining participant level documentation, and collecting, processing, and transporting research specimens. This position will work alongside and interact with multiple team members including: research staff, clinic staff and providers, surgeons, OR staff and hospital staff. Experience in Women's health research is preferred. 

 

This position is 100% on site. 

Minimum Requirements: 

Education/Training 

Work requires an Associate's degree 

Experience 

Work requires a minimum of six years of research experience. A Bachelor's degree may substitute for 2 years required experience. 

 

 

Be Bold. 

· Operations: Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. 

· Addresses and corrects findings. May train others. 

· Maintain all participant level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. 

· Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. 

· Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. 

· Screens participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs. 

· Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. 

· Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). 

· Schedules participants for research visits (excluding those requiring EHR access). 

· Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol. 

· Conducts and documents non-complex visits and scripted testing or interviews. 

· May manage participant payment. 

· Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders. Ethics: 

· Identifies all Adverse Events, 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. 

· Assists with the development of consent plans and documents for participants. 

· Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review. 

· 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. 

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