Clinical Research Coordinator - Department of Dermatology

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 2,500 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.

Duke University’s School of Medicine - Department of Dermatology has an immediate need for a Clinical Research Coordinator located in Durham, N.C. More information about this department is located at the following link:

 https://dermatology.duke.edu/research

 

Occupational Summary

This position will work in a small team of coordinators in the Dermatology Research Unit on both Principal Investigator (PI) initiated and Industry funded studies of all phases for adult subjects.

The ideal candidate will have experience with clinical research and possess basic phlebotomy skills or be willing to learn with training.  The candidate may train or oversee others in all policies and procedures.

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 all policies and processes.

Responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding.

Prepares for, provides support for study monitoring, and audit visits, including support for the reviewer. Addresses and corrects findings. 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.

Employs strategies to maintain retention rates. Evaluates 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 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). Conducts and plans for complex study visits. May train staff. Participates in study team meetings.

 

 

 

Ethics:
 

Identifies all adverse events (AE), and determines whether they are reportable.  Collaborates with the PI to determine AE attributes, including relatedness to study.

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. Develops consent plans and documents for participants in a variety of studies.

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. Ensures accuracy and completeness of data for all studies, including those that are complex in nature.

Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance.

In addition, recognizes and reports security of physical and electronic data vulnerabilities. Independently uses and implements technology to enhance productivity or process.

Study and Site Management:
 

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activities, calendars