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 has an immediate opening for a Clinical Research Coordinator. This position will involve clinical research activities with the Urogynecology research team.

Urogynecology is a medical discipline focused on pelvic floor issues including vaginal prolapse, bladder control issues, bowel control issues, and recurrent urinary tract infections. Given the breadth of our research program, we are looking to add an additional research coordinator to our experienced team. We are specifically looking for a highly motivated, team-oriented individual to integrate into several NIH-funded and industry-funded trials. This is an in-person position which will require rotating days between our two clinical offices (one in Durham and one in Raleigh).  

Operations:
Knowledgeable in regulatory and institutional policies and processes; applies these appropriately in study documentation, protocol submissions, and SOPs. Recruits research participants according to study protocol. Screens participants for simple and complex studies (e.g., procedural and interventional studies). 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. 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. Participates in study team meetings. Employ strategies to maintain participant retention in clinical studies. May train or oversee others in all of the above activities. 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.
Ethics:
Knowledgeable in data security, safeguarding participant privacy, and ethical conduct of research. 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. 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. May train or oversee others. 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 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. In addition, recognizes and reports security of physical and electronic data vulnerabilities. Learns and uses new technology when required. Assists in updating reports on study progress for the Principal Investigator and other study team members and collaborators.
Science:
Under guidance, develops elements of research protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs.
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, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits. May train others. Records basic protocol information in clinical research management system. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. May train or oversee others. Ensure 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).
Leadership:
Proactively seeks opportunities to add relevant skills and certifications to own portfolio. 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 committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. 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. Education/Training

Completion of an Associate's degree

Experience

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

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

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 jobsat Duke University and Duke University Health System may include essential job 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.