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.

Be You.

Duke University's Department of Obstetrics and Gynecology has an immediate on - site position supporting multiple research studies in the Gynecologic Oncology division, conducted by multiple investigators. This portfolio only includes non-treatment oncology trials. Duties will include screening for research studies, obtaining written consent, conducting study visits, maintaining participant level documentation, and collecting, processing, and transporting research specimens. This position will work alongside and interact with multiple team members including: research staff, clinic staff and providers, surgeons, OR staff and hospital staff. Experience in Women's health research is preferred.

This position is 100% on site.

Minimum Requirements:

Education/Training

Work requires an Associate's degree

Experience

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

Be Bold.

* Operations: Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.

* Addresses and corrects findings. May train others.

* Maintain all participant level documentation for studies 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). Develops or helps develop SOPs.

* Collects, prepares, processes, ships, and maintains the inventory of human 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).

* Schedules participants for research visits (excluding those requiring EHR access).

* Prepares necessary documents, equipment, supplies, etc. in compliance with the protocol.

* Conducts and documents non-complex visits and scripted testing or interviews.

* May manage participant payment.

* 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.

* 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.

* 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 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. Science:

* Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship). 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 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. Prepares studies for closeout and document storage. May train or oversee others. 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. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.

* Actively facilitates and leads multiple study team's adoption of change in their working environment.

* Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams.

* Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Choose Duke.

Join our award-winning team as identified by Forbes magazine as America's Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work.

Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines.

Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more.