Clinical Research Nurse Coordinator

Duke Careers•Durham, NC

2d•$66,265 - $107,096•Onsite

About The Position

As the Gastroenterology (GI) Clinical Research Nurse Coordinator (CRNC), you will support the divisional research portfolio by utilizing clinical nursing assessment skills to plan, provide, supervise, and document professional nursing care for research participants. This involves adhering to physician orders, study protocols, and established policies and procedures. Key responsibilities include reviewing complex electronic medical records for participant eligibility, conducting ongoing participant assessments, educating participants, monitoring participant safety and adverse events (AEs/SAEs), and exercising professional nursing judgment. You will liaise closely with research participants, investigators, physicians, and clinic staff. The role may involve supervising other licensed and unlicensed research staff. Specific duties include administering IV, SQ, oral, and rectal drugs, consenting participants, conducting subject visits, collecting/processing/shipping specimens, managing investigational products (IP), data entry, query resolution, processing participant payments, reviewing research billing, maintaining subject and study documentation, and assessing logistics for study implementation. You will ensure compliance with study protocols and regulatory requirements, and support data analysis. This position is integrated into a larger clinical research team, collaborating on studies to advance the GI Division's research mission while upholding ethical research conduct and participant protection. You will report directly to the GI Division's Research Program Leader (RPL), with Principal Investigators providing scientific oversight, regulatory guidance, mentorship, and supervision.

Requirements

Graduation from an accredited BSN or an Associate Degree in Nursing or Nursing Diploma program.
Current or compact RN licensure in the state of North Carolina.
Basic Life Support (BLS) certification required.
Maintain compliance with required hospital and unit-specific training competencies.
Maintain active RN status with the North Carolina Board of Nursing (NCBON).
Twelve months of appropriate clinical nursing experience is required.
All registered nurses without a Bachelor 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.

Nice To Haves

Previous clinical research experience

Responsibilities

Utilize clinical nursing assessment skills to plan, provide, supervise, and document professional nursing care for research participants.
Review complex electronic medical records for participant eligibility.
Conduct ongoing participant assessments.
Educate participants on study protocols and procedures.
Monitor participant safety and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
Administer IV, SQ, oral, and rectal drugs.
Obtain informed consent from participants.
Conduct subject visits according to study protocols.
Collect, process, and ship specimens.
Manage investigational products (IP), including arrival, storage, tracking, and provision.
Perform data entry and resolve data queries.
Process participant payments.
Review research billing for accuracy.
Maintain comprehensive subject and study documentation.
Assess logistics for study implementation.
Ensure compliance with study protocols and regulatory requirements.
Support data analysis.
Collaborate with a clinical research team to advance the research mission.
Supervise the activities of other licensed and unlicensed research staff (may be required).
Prepare FDA regulatory submissions in collaboration with ORAQ.
Address FDA review and/or potential hold issues.
Prepare for and provide support for study monitoring and audit visits.
Maintain participant-level documentation for studies.
Employ strategies to maintain participant retention rates.
Evaluate processes to identify problems with retention and recruitment.
Screen participants for studies.
Develop or assist in developing Standard Operating Procedures (SOPs).
Collect, prepare, process, ship, and maintain inventory of human research specimens.
Maintain study-level documentation for all studies.
Conduct activities for study visits in compliance with the protocol.
Contribute to team meetings and potentially lead multidisciplinary meetings.
Identify and determine reportability of all AEs.
Collaborate with the PI to determine AE attributes.
Develop consent plans and documents for participants.
Develop and submit documentation for Institutional Review Board (IRB) review.
Communicate with IRB staff and reviewers.
Prepare and submit documents for regulatory and safety reporting.
Enter and collect research data.
Develop research data entry or collection tools.
Ensure accuracy and completeness of data.
Recognize data quality trends and escalate as appropriate.
Develop tools for and train others in data quality assurance procedures.
Recognize and report security of physical and electronic data vulnerabilities.
Develop or review data lifecycle and management plans.
Demonstrate and apply open science practices and FAIR data principles.
Prepare data for deposit in repositories.
Map a protocol's data workflow.
Innovatively use technology to enhance a research process.
Prepare tables, data visualizations, and lay summaries to communicate study results.
Develop reports on study progress.
Assist with or contribute to the development of funding proposals.
Independently conduct literature searches and reviews.
Develop elements of research protocols.
Contribute to the development of scientific publications or presentations.
Serve as an author on poster presentations or publications.
Prepare for, coordinate, and actively participate in site visits.
Communicate effectively with sponsors and/or CROs.
Use clinical research management systems and EHR functionalities to manage participant activities and study visits.
Use OnCore and eREG systems to manage research protocols.
Determine the feasibility of study team participation in specific trials.
Ensure adequate supplies and equipment are available and in good working order.
Ensure studies are conducted in compliance with institutional requirements and policies.
Follow, and may develop or implement, operational plans.
Prepare studies for closeout and document storage.
Work with the manager to understand areas of opportunity and develop a training plan.
Keep current with research updates by attending key external offerings and applying learned material.
Serve on committees and workgroups.
Navigate processes and people involved in Duke clinical research.
Develop and implement solutions within the existing leadership or organizational structure.
Demonstrate resilience and adaptability to change.
Use advanced subject matter expertise to solve problems.
Communicate effectively with others to accomplish shared work objectives.