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.

 

Duke University’s Department of Obstetrics and Gynecology have an immediate opening in their Maternal Fetal Medicine division research team for a Clinical Research Coordinator.

 

Occupational Summary

This position will be part of the Perinatal Research team, which conducts studies in pregnant and postpartum individuals, as well as their babies both in the outpatient and inpatient settings. We are specifically looking for a highly motivated, team-oriented individual to integrate into a number of grant, foundation and industry-funded non-treatment trials.

 

This is an on-site position based at the Perinatal Research Center in Durham, with travel to outlying prenatal clinics in Durham and Wake Counties.

 

This position is required to work 4 10-hour days (including 1 weekend per month). This position is required to be available for on call work. Spanish fluency is strongly preferred.

 

Operations:

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.

 

May train others in a variety of processes, policies and procedures. May oversee the work of other staff members.

 

Prepares for and 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.

 

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). Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.

 

Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Conducts activities for study visits in compliance with the protocol.

 

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 Principal Investigator to determine adverse event 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. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. 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. Innovatively uses technology to enhance a research process. May train others.

 

Assists in updating reports on study progress for the Principal Investigator and other study team members and collaborators. Science: Demonstrates a basic under