Clinical Research Nurse Coordinator

Duke Careers•Durham, NC

1d•Onsite

About The Position

The Clinical Research Nurse Coordinator position at Duke University School of Medicine is a comprehensive role focused on managing clinical trials, specifically within Urology and Urology Oncology. This role is integral to Duke Health, a world-class academic medical center, and involves a broad spectrum of responsibilities from regulatory compliance and participant management to data collection, scientific contributions, and team leadership. The coordinator will handle FDA regulatory submissions, manage investigational products, ensure participant retention and recruitment, and maintain meticulous study documentation. Key aspects include conducting and documenting informed consent, managing adverse events, and ensuring data accuracy and security. The role also involves contributing to scientific publications and funding proposals, coordinating site visits, and utilizing clinical research management systems. Additionally, the position includes direct clinical responsibilities such as medication administration and basic dysrhythmia review. The coordinator is expected to demonstrate leadership by training and overseeing other team members, facilitating meetings, and continuously seeking professional development.

Requirements

Knowledgeable in regulatory and institutional policies and processes.
Phlebotomy experience.

Nice To Haves

Nursing experience in Urology preferred.

Responsibilities

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation.
Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI).
May train or oversee others in regulatory and institutional policies and processes.
Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs).
Maintains study level documentation for international studies.
May develop resources and tools for management of international studies, and/or coordinate with other entities or offices.
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 from monitoring/audit visits.
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.
Escalates issues related to recruitment.
Screens participants for greater than minimal risk or 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).
Provides oversight and training and lends expertise to multiple study teams.
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.
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 research data.
Develops research data entry or collection tools.
May provide oversight or training to study team members collecting or entering research data.
Ensures accuracy and completeness of data for all studies, including those that are greater than minimal risk or complex in nature.
Recognizes data quality trends and escalates as appropriate.
May develop tools for, and train others in, data quality assurance procedures.
Recognizes and reports security of physical and electronic data vulnerabilities.
May develop or review data lifecycle and management plans for multiple study protocols.
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.
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.
Assists with or contributes to the development of funding proposals.
Assists with simple literature searches.
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 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.
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.
Ensure 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.
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.
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.
Establishes and assigns the activities of the research program team members to accomplish the study goals.
Ambulatory Medication Administration
Adult Medication
Pediatric Medication
OR Medication
Alaris Pump Set up and Use
Basic Dysrhythmia Review