Clinical Research Nurse Coordinator

Duke Careers•Durham, NC

1d•Hybrid

About The Position

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. 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.

Requirements

Graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program.
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).
Twelve months of appropriate clinical nursing experience is required.

Nice To Haves

Easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).
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.
Registered nurses hired before September 1, 2016 are not required to enroll in a BSN program to remain in this job classification.
May train others in these policies and processes.
May train others.
May train or oversee others.
May disseminate information to others.

Responsibilities

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.
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.
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
Addresses and corrects findings.
Maintains all participant level documentation for studies that are greater than minimal risk or complex in nature (e.g., procedural and interventional studies).
Employs strategies to maintain retention rates.
Evaluates processes to identify problems with retention.
Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems.
Screens participants for greater than minimal risk or complex studies (e.g., procedural and interventional studies).
Develops or helps develop SOPs.
Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
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.
Identifies all AEs, 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 greater than minimal risk or complex in nature and/or require any orders in Maestro Care.
Develops consent plans and documents for participants in a variety of studies.
Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Enters and collects research data.
Develops research data entry or collection tools.
Follows required processes, policies, and systems to ensure data security and provenance.
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.).
Innovatively uses technology to enhance a research process.
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.
Independently conducts literature searches and reviews.
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.
Uses OnCore and eREG systems and system reports to manage research protocols.
Collects appropriate information to determine whether the study team's participation in a specific trial is feasible.
Makes feasibility recommendations.
For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.
Forecasts effort needs.
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).
Prepares studies for closeout and document storage.
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.
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.
General knowledge from previous nursing experience and the ability to place orders independently.
Be agile in a fast paced acute environment and manage multiple study priorities.