CLINICAL RESEARCH NURSE COORDINATOR

Duke Careers • Durham, NC

13d • Onsite

About The Position

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Occupational Summary
Participates in or leads day to day operations of clinical research studies conducted by Principal Investigator(s) (PI) at Duke Medicine; performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks. Provides and documents professional nursing care for research participants.

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 BSNprogram to remain in this job classification.
• Twelve months of appropriate clinical nursing experience is required.

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.
• Maintains study level documentation for international studies.
• 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.
• 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 complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR.
• 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 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).
• Conducts activities for study visits in compliance with the protocol.
• Contributes to the effective facilitation of team meetings to achieve predetermined objectives.
• 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 complex in nature and/or require any orders in Maestro Care.
• Develops consent plans and documents for participants in a variety of studies.
• Develops and submits documentation for IRB review in iRIS.
• Communicates with the IRB staff and reviewers and handles issues appropriately.
• Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
• Enters and collects data.
• Develops data entry or collection SOPs or tools.
• Ensures accuracy and completeness of data for all studies, including those that are complex in nature.
• Recognizes data quality trends and escalates as appropriate.
• Recognizes and reports security of physical and electronic data vulnerabilities.
• May develop or review data lifecycle and management plans for multiple study protocols.
• Demonstrates and applies open science practices and the FAIR data principles.
• Prepares data for deposit in repositories following publication or study closeout.
• Locates and follows repository-specific requirements to submit study data for sharing.
• May draft data sharing plans for clinical studies that ensure data and documentation will support re-use.
• Understands and is able to identify when various data standards should be used in creating ECRFs and EDCs, and integrates according to best practices (E.g. IDC 10, CDISC, MedDRA, and WHODrug).
• Demonstrates awareness of common data elements for research and understands how they would be applicable to their protocol(s).
• 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.
• Prepares tables, data visualizations, and lay summaries to communicate study results to participants.
• Assists in updating reports on study progress for the PI and other study team members and collaborators.
• Independently conducts literature searches and reviews.
• Develops elements of research protocols using scientific proposals from the PI.
• Demonstrates a basic understanding of the elements of research study designs.
• Contributes to the development of scientific publications or presentations.
• Serves as an author on poster presentations or publications.
• 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.
• 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.
• For studies with 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.
• Follow, 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.
• Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
• Develops and implements solutions that work within the existing leadership or organizational structure.
• 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.
• Adult Medication
• Peripheral IV Insertion and Maintenance
• Alaris Pump Set up and Use
• Draw blood from arterial lines

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree