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:

• Recognizes when agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.

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

• Prepares for and supports study monitoring and audit visits, including supporting the reviewer and addressing findings.

• Maintains participant-level documentation for all studies, including complex ones (e.g., procedural and interventional studies) that require access to the Duke EHR.

• Employs strategies to maintain retention rates, evaluate retention processes, and identify issues.

• Screens participants for all studies, including complex ones. Provides oversight and training in screening activities to multiple study teams.

• Develops or helps develop SOPs.

• Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens.

• Maintains study-level documentation for all studies.

• Conducts study visits in compliance with the protocol and may train staff.

• Contributes to and may lead multidisciplinary team meetings.

Ethics:

• Identifies and determines the reportability of all AEs, collaborating with the PI.

• Conducts and documents consent for participants for all study types, including complex studies requiring orders in Maestro Care.

• Develops consent plans and documents for various studies.

• Prepares and submits regulatory and safety documents to sponsors and agencies.

Data:

• Enters and collects data, developing data entry or collection SOPs or tools.

• Provides oversight or training to study team members on data collection and entry.

• Ensures data accuracy and completeness for all studies, including complex ones.

• Recognizes data quality trends and escalates as appropriate.

• Develops tools for and trains others in data quality assurance procedures.

• Follows processes, policies, and systems to ensure data security and provenance.

• Uses technology innovatively to enhance research processes and may train others.

• Assists in updating and developing study progress reports.

Study and Site Management:

• Prepares for, coordinates, and actively participates in site visits.

• Communicates effectively with sponsors and CROs.

• Uses clinical research management systems to manage research participants' activities, calendars, and study visits.

• Collects appropriate information to determine the feasibility of study team participation in trials and may make recommendations.

• Ensures supplies and equipment are sufficient and in good working order.

• Conducts studies in compliance with institutional requirements and policies.

• Prepares studies for closeout and document storage.

Leadership:

• Seeks opportunities to add relevant skills and certifications.

• Keeps current with research updates and applies learned material.

• Serves on committees and workgroups, demonstrating interpersonal skills to optimize research processes.

• Demonstrates resilience and adaptability to change.

• Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.

• Communicates effectively to accomplish shared work objectives.

Description of Portfolio Responsibilities: (Effort .%)

Description of Clinical Responsibilities:

• Ambulatory Medication Administration

• Adult Medication

• OR Medication

• Draw blood from arterial lines

Type of Research:

• Supports clinical research trials in Trauma, Acute, and Critical Care Surgery Research.

• Recruits study participants in the Emergency Department, ICUs, and other hospital units.

• May require on-call duties during off-hours and weekends.

• Requires maintaining a cellphone and home workspace with adequate internet service.

Special Skills:

• Nutrition education or experience is highly desired.

• Emergency Department or ICU experience is recommended.

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, which thrives when the diversity of 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 are responsible for upholding 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:

• Requires 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 and active RN status with the North Carolina Board of Nursing (NCBON).

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.