Clinical Research Coordinator - Obstetrics and Gynecology

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 Department of Obstetrics and Gynecology has an immediate opening for a Clinical Research Coordinator in their Maternal Fetal Medicine division. 

 

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. Ability to work 4 10-hour days is preferred. This position is required to take on-call. Spanish fluency is strongly preferred. May train or oversee others in the areas below. 

Operations: 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. Assists with establishing and maintaining study level documentation. 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 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. 

 

Assists with the development of consent plans and documents for participants. Data: Enters and collects basic data for research studies. May score scripted or validated tests and measures. 

Follows required processes, policies, and systems to ensure data security and provenance. 

In addition, recognizes and reports security of physical and electronic data vulnerabilities. Learns and uses new technology when required. Study and Site Management: As directed, attends or schedules site visits. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. 

Uses required EMR functionalities to manage participants and study visits. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. 

Ensure that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows. Leadership: Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. 

Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. 

May disseminate information to others. Serves on committee