CLINICAL RESEARCH NURSE COORDINATOR

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 2,600 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.

This position is for a Clinical Research Nurse Coordinator within the Duke Neonatal-Perinatal Research team and will support projects involving families and neonates. The position will work with multiple investigators and other members of the team on clinical research studies. Biological samples will be collected and processed from neonates/parents per protocol. The responsibilities and duties will require this position to primarily work in person with some opportunities for hybrid local remote work. Previous work with federal multi-site grants or neonatal nursing experience is preferred but not required. 

Type of Research:
Position will manage multiple neonatal clinical research studies including those that are complex in nature. The position will work within a team environment and communicate/interact with unit clinician and nursing staff

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). Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. 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. Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. Screens participants for complex studies (e.g., procedural and interventional studies). 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. 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.

Ethics:
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 and information for IRB review. 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 data.  Develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are 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 flow plan 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.

Science:
Assists with or contributes to the development of funding proposals. Assists with simple literature searches. Using scientific proposals from the PI, develops elements of research protocols. 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 financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits.  Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make 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. 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. May train or oversee others.

Leadership:
Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Provides opportunities for staff to attend key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.).  Plays key role on committees and workgroups. 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.


Description of Portfolio Responsibilities:

Research Activities: (Effort 60%)

·       Provide clinical research coordination and implementation for assigned pediatric neonatal-perinatal clinical research projects

·       Provide support on federally funded multi-site clinical research projects including the Neonatal Research Network

·       Consent patients to assigned studies including but not limited to interventional, observational, and retrospective research

·       Collect and process collected samples and prepare for cold storage or shipping per protocol.

·       Complete School of Medicine and Sponsor electronic study management systems, including but not limited to iRIS, OnCore, MaestroCare

·       Collect and review clinical data as needed per protocol and enter into appropriate clinical report form (CRF/eCRF)

·       Conduct initial study eligibility screening and review with PI

·       Collect and process research samples, including biologics

·       Laboratory processing and shipping of research samples

·       Participate in team meetings, providing updates to PI and team

·       Provide routine updates to PI’s and study team

Regulatory Support: (Effort 10%)

·       Prepare regulatory submissions through approval for multiple studies and maintain regulatory files through the life cycle of the study

·       Participate in monitoring visits, resolving all issues identified by the sponsor or its representative

·       Communicate with sponsor on behalf of PIs regarding all regulatory and study startup processes

·       Maintain regulatory binders for assigned projects

·       Develop and submit documentation and information for IRB review

·       Communicate with the IRB staff and reviewers and handle issues appropriately

·       Prepare required progress reports for federally funded research projects

·       Prepare draft budgets in support of study start-up and clinical research unit (CRU) feasibility assessments

·       Coordinate submission of CRU scientific and financial feasibility review documents

Data: (Effort 30%)

·       Ensure the accurate and timely collection of protocol identified data

·       Collect clinical data as needed per protocol and enter into appropriate CRF/eCRF

·       Ensure data security and integrity in alignment with School of Medicine requirements

·       Ensure timely entry of data into study established databases

Description of Clinical Responsibilities:

Clinical responsibilities:
• Ambulatory Medication Review/Administration
• Pediatric Medication Review/Administration
• Peripheral IV Insertion and Maintenance
• Draw blood from arterial lines


Special skills:
Previous neonatal and/or research experience preferred but not required.

Education

Work requires graduation from an accredited BSN or Associates Degree inNursing or Nursing Diploma program. All registered nurses without a Bachelors degree in Nursing (or higher) are encouraged to enroll in anappropriate 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 NorthCarolina. 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 BSN program to remain in this job classification.

Experience

Twelve months of appropriate clinical nursing experience is required.

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