Clinical Research Nurse Coordinator

Clinical Research Nurse CoordinatorWork Arrangement: On-SiteLocation: Durham, NC, US, 27710School 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. 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 utilizing the nursing process for research participants in accordance with physician orders, study protocols, and established policies and procedures. Responsibilities include review of complex electronic medical records for participant eligibility, conducting ongoing participant assessments, participant education, clinical monitoring of participant safety and AEs/SAEs, and exercising professional nursing judgment while conducting research activities and closely liaising with research participants, investigators, physicians, and clinic staff. You may supervise the activities of other licensed and unlicensed research staff. This position will perform a variety of professional nursing research activities, including IV, SQ, oral, and rectal drug administration. Additional responsibilities include consenting, conducting subject visits, specimen collection/processing/shipping, IP management, data entry, query resolution, participant payment processing, research billing review, subject and study documentation, assessing logistics for study implementation, ensuring compliance with study protocols and regulatory requirements, and supporting data analysis. You will be integrated into a larger clinical research team and is expected to collaborate on studies that further the research mission of the GI Division while ensuring the ethical conduct of research and protection of research participants. You will report directly to the GI Division's Research Program Leader (RPL). Principal Investigators will provide scientific oversight, regulatory guidance, mentorship, and supervision in the conduct of research.Minimum Requirements: Work requires graduation from an accredited BSN or an Associate Degree in Nursing or Nursing Diploma program. 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. 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). Twelve months of appropriate clinical nursing experience is required.Preferred Qualifications: Previous clinical research experienceThe Gastroenterology (GI) Clinical Research Nurse Coordinator (CRNC) will support the divisional research portfolio by utilizing clinical nursing assessment skills to plan, provide, supervise, and document professional nursing care utilizing the nursing process for research participants in accordance with physician orders, study protocols, and established policies and procedures. This position will perform a variety of professional nursing research activities, including IV, SQ, oral, and rectal drug administration. This position is Onsite. The work is performed on-site or at a designated assignment location.Be Bold. Operations: 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. Knowledgeable in regulatory and institutional policies and processes. Applies knowledge to assist with study documentation, protocol submissions, and standard operating procedures (SOPs). Assists with study level documentation and approvals 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. 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. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. 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. 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. 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. 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. 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. 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. 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.Science: Assists with or contributes to the development of funding proposals. 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.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. 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). May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.Leadership: Works with the manager to understand areas of opportunity and develop a training plan. Takes training courses and applies the knowledge and skills. May also train others in the skills learned. Keeps current