CLINICAL RESEARCH COORDINATOR - Department of 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 tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Duke’s Department of Obstetrics and Gynecology has an immediate opening for a Clinical Research Coordinator who will be part of the Perinatal Research Center team.
More information about the center is located at the following link: https://obgyn.duke.edu/research/active-research-programs/duke-perinatal-research-center
100% Grant funded
This applicant will be involved in both non-complex and complex research studies for populations involving primarily pregnant women. Daily interactions with team members is required.
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.
Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering).
Under supervision, prepares for study monitoring and audit visits. Maintains participant-level documentation for non-complex (e.g., questionnaire, data registry, scripted) studies outside of the EHR.
Follows SOPs and strategies to manage and retain research subjects. Recruits research participants according to study protocol. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others.
Follows SOPs. Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. Assists with establishing and maintaining study level documentation.
Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews. May manage participant payment. Participates in study team meetings.
Recognizes known potential adverse events, identified in the protocol or investigator brochure, and reports to study team. 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.
Under supervision, for non-complex studies (e.g., survey studies and registries), develops and submits documentation and information for IRB review. Data:
Enters and collects basic data for research studies. May score scripted or validated tests and measures. 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. Learns and uses new technology when required.
Demonstrates a basic understanding of the elements of research study designs.
Study and Site Management:
As directed, attends or schedules site visits. Records participant accrual information and consent documentation for non-complex studies in clinical research management system.
For studies with simple supplies or equipment, assists with ensuring that there are ample supplies and that equipment is in good working order.
Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows protocol-specific systems and process flows.
As directed, assists in preparing studies for closeout, (e.g., packing files, documenting files for storage, shipping extra supplies back to sponsor).
Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN, additional training, etc.). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.
Completion of an Associate's degree
Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.
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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.