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.

Operations:

• Knowledgeable in regulatory and institutional policies and processes; applies them appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes.

• Under supervision, assists with managing investigational products including arrival, storage, and handling (requisitions, inventory, and reordering).

• Prepares for study monitoring and audit visits under supervision.

• May document some participant-level information for non-complex studies (e.g., questionnaires, data registry, scripted) outside of the EHR.

• Follows SOPs and strategies to manage and retain research subjects.

• Recruits research participants according to study protocol.

• Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others.

• Employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens under supervision.

• Assists with establishing and maintaining study-level documentation.

• Schedules participants for research visits (excluding those requiring EHR access).

• Prepares necessary documents, equipment, supplies, etc., in compliance with the protocol.

• Conducts and documents non-complex visits and scripted testing or interviews.

• May manage participant payment.

• 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 the study. May train or oversee others.

• 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. May train or oversee others.

• Develops consent plans and documents for participants in various studies. May train or oversee others.

• 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 complex ones.

• Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures.

• Recognizes and reports security vulnerabilities of physical and electronic data. May develop or review data lifecycle and management plans for multiple study protocols.

• Knowledgeable about requirements for depositing data and following repository and metadata specifications for data sharing. With guidance, locates and follows repository-specific requirements to submit study data for sharing.

• Understands and identifies when various data standards should be used in creating eCRFs and EDCs and integrates them according to best practices (e.g., IDC 10, CDISC, MedDRA, and WHODrug).

• Aware of common data elements for research and understands their applicability to protocol(s).

• 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.). May train or oversee others.

• Learns and uses new technology when required. Assists with merging multiple datasets, recoding variables, and resetting scoring scales under supervision.

• Performs de-identification on datasets to Safe Harbor standards as permitted by the protocol and contracts (e.g., DTA, DUA, and CTA). May act as a federated honest broker for PACE.

• 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 communicate key information to stakeholders.

Science:

• Assists with or contributes to the development of funding proposals. Uses expertise in research design to provide significant contributions to protocols or research proposals.

Study and Site Management:

• Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs.

• Uses clinical research management systems 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. May train others.

• Records basic protocol information in the clinical research management system.

• 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. May train or oversee others.

• Ensures 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.

• Assists in preparing studies for closeout, including packing files, documenting files for storage, and shipping extra supplies back to the sponsor.

Leadership:

• Maintains Duke and project-specific training requirements. Keeps current with research updates by attending key external offerings (e.g., Research Wednesday, RPN, events outside of Duke) and applies learned material to the job. May disseminate information to others.

• Serves on committees and workgroups internal to Duke or externally in the therapeutic area of research.

• Navigates processes and people involved in Duke clinical research, demonstrating the organizational awareness and interpersonal skills necessary to get work done efficiently.

• Demonstrates resilience and adaptability to change.

Description of Portfolio Responsibilities: (Effort .%):

Description of Clinical Responsibilities:

Clinical responsibilities:

• OR Medication

• Alaris Pump Set up and Use

Type of Research:

• Responsible for interventional device and potentially drug clinical trials in cardiothoracic surgery. These will be medium to difficult clinical trials. They will be trained and supervised by an ARPM.

Special Skills:

• Ability to multitask and handle the demands of interventional trial management and recruitment.

Minimum Qualifications:

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunities without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our success depends on the robust exchange of ideas—an exchange that is best when the diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all community members feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All community members have a responsibility to uphold these values.

Anticipated Pay Range:

Duke University provides an annual base salary range for this position as USD $63,692.00 to USD $102,937.00. Duke University considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, internal peer equity, and market and organizational considerations when extending an offer.

Your total compensation goes beyond the dollars on your paycheck. 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. Learn more at: https://hr.duke.edu/benefits/

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provisions for requests for reasonable accommodation will be provided by each hiring department.

Education:

• Graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor's degree in Nursing (or higher) are encouraged to enroll in an appropriate BSN program within two years of their start date and 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 BSN program to remain in this job classification.

Experience:

• Twelve months of appropriate clinical nursing experience is required.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.