Clinical Research Nurse 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.

The Department of Surgery is looking for a Clinical Research Nurse Coordinator to join our team. This critical role will participate in or lead the day-to-day operations of clinical research for the Cardiovascular and Thoracic Division. The Surgery Office of Clinical Research (SOCR) is staffed with experienced individuals who are dedicated to patient safety while conducting innovative research with the hope of advancing medicine and improving clinical care.

Minimum Requirements:

• Work requires graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelors degree in Nursing (or higher) are encouraged to enroll in an appropriate BSN program within two years of their start date but must complete the program within seven years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required.
• Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON).
• Exception: Registered nurses hired before September 1, 2016 are not required to enroll in a BSN program to remain in this job classification.
• Twelve months of appropriate clinical nursing experience is required.

Preferred Qualifications:

• Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).

Other Requirements:

• This position is onsite. The employee must reside in a Duke University-approved state.

Be Bold.

Position Description:

Operations:
Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. 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. Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains all participant level documentation for studies that are greater than minimal risk or complex in nature (e.g., procedural and interventional studies). May train or oversee others. Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants for greater than minimal risk or complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). May train or oversee others. Conducts activities for study visits in compliance with the protocol. May train staff. Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.


Ethics:
Identifies all AEs, 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 greater than minimal risk or complex in nature and/or require any orders in Maestro Care. May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.


Data:
Enters and collects research data. Develops research data entry or collection tools. May provide oversight or training to study team members collecting or entering research 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. Maps a protocol's data workflow including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). May train or oversee others. Innovatively uses technology to enhance a research process. May train others. Develops reports on study progress for the PI and other study team members and collaborators. Creates clear visualizations to help communicate key information to stakeholders.


Science:
Independently conducts literature searches and reviews.


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 of financial milestones, and all aspects of study visits. Uses required EHR functionalities to manage participants and study visits. May train others. Uses OnCore and eREG systems and system reports to manage research protocols. May train or oversee others. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make feasibility recommendations. 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. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). May train or oversee others. 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. 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.


Clinical responsibilities:
• Other: General knowledge from previous nursing experience and the ability to place orders independently


Type of Research:
The Clinical Research Professional (CRP) in the Cardiothoracic Research Division within Surgery is a specialized research team member responsible for coordinating and executing complex clinical trials involving investigational medical devices, including greater-than-minimal risk studies conducted under an Investigational Device Exemption (IDE). Working under the direction of the Principal Investigator, the CRP ensures studies are conducted safely, ethically, and in compliance with Good Clinical Practice (GCP), FDA regulations, and institutional policies, while managing patient screening and enrollment, facilitating informed consent, overseeing regulatory submissions, and maintaining accurate data and device accountability. This role requires close coordination with multidisciplinary cardiothoracic teams in high-acuity environments such as the operating room and ICU, as well as communication with sponsors and regulatory bodies, to support protocol adherence, monitor adverse events, and ensure audit readiness. Through this work, the CRP serves as a critical bridge between clinical care and research, safeguarding patient safety and advancing innovative device therapies in cardiothoracic surgery.


Special skills:
Be agile in a fast paced acute environment and manage multiple study priorities

Choose Duke.

The Duke Department of Surgery has gained a reputation as one of the leading surgery programs in the world. The number and variety of active clinical trials in the Department of Surgery allows us to offer our patients access to treatments and therapies that are available at only a few medical centers nationwide. Join our award-winning team and be part of an inclusive culture that is committed to providing outstanding patient care, training tomorrow's leaders, and conducting innovative research. 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.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $64,966.00 to USD $104,996.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.


Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at:


Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.


Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.



Essential Physical Job Functions:
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: View email address on click.appcast.io; phone: View phone number on click.appcast.io).