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Job Code: 1203
Job Level: 54
Revised Date: 05/01/2019
Job Family: JF 05

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Occupational Summary

Participate in or lead day to day operations of clinical research studies conducted by principal investigator(s) at Duke Medicine; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks. Provide and document professional nursing care for research participants.

Work Performed

Nursing activities.

Plan, provide, supervise, and document professional nursing care utilizing the nursing process for patients in accordance with physician orders and established policies and procedures.

Use professional nursing judgment when conducting nursing research activities to patients.

May delegate tasks and supervise the activities of other licensed and unlicensed research staff.

Monitor and initiate corrective action to maintain the environment of care, including equipment and material resources.

Participate in the identification of clinical or operational performance improvement opportunities and in performance improvement activities.

Research Operations.

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs).

Screen participants for complex studies (e.g., procedural and interventional studies).

Develops or helps develop SOPs.

Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems.

Escalates issues.

Conducts and plans for visits for complex studies (e.g., procedural and interventional studies).

Maintains participant level and study level documentation for all studies, including those that are complex in nature and/or require access to the Duke electronic health record (EHR).

Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.

Addresses and corrects findings.

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, Investigational Drug Service (IDS), and other parties as necessary.

Follows protocol schema for randomization and blinding/unbinding.

Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures.

May maintain study level documentation for international studies and develop resources and tools for management of international studies, and/or coordinate with other entities or offices.

May prepare Federal Drug Administration (FDA) regulatory submissions in collaboration with Office of Regulatory Affairs and Quality (ORAQ), including development, submission, and maintenance of relevant documentation.

Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI).

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Leads meetings that are multidisciplinary, including those with complex objectives.

Safety and Ethics.

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 Institutional Review Board (IRB) review.

Communicates with the IRB staff and reviewers and handle issues appropriately.

Identifies all adverse events (AEs), and determines whether or not they are reportable.

Collaborates with the PI to determine AE attributes, including relatedness to study.

Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.

Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations.

Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.


Enters and collects data, and 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.

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 research data security plans (RDSPs) for multiple study protocols.

Maps a protocols data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).

Independently uses and implements technology to enhance productivity or process.

Scientific Concepts.

Assists with or contributes to the development of funding proposals.

Using scientific proposals from the PI, develops research protocols.

Demonstrates a basic understanding of the elements of research study designs.

Independently conducts literature searches and reviews.

Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.

Site and Study Management.

Collects appropriate information to determine whether the study teams participation in a specific trial is feasible.

May make feasibility recommendations.

Ensures that studies are conducted in compliance with institutional requirements and other policies.

Follows, and may develop or implement, protocol specific systems and documents including process flows.

Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or contract research organizations (CROs).

For studies with complex supplies or equipment, ensures that there are ample supplies and that equipment is in good working order.

May forecast staffing needs.

Uses systems and system reports to manage research participants activities and charge routing.

Prepares studies for closeout and document storage.

Leadership and professionalism.

May train or oversee others in the above tasks.

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.

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

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

May serve on committees and workgroups internal to Duke or externally in therapeutic area of research.

Demonstrates resilience and is adaptive to change.

Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Required Qualifications at this Level


Work requires graduation from an accredited BSN or Associates Degree in Nursing or Nursing Diploma program.

All registered nurses without a Bachelors degree in Nursing (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five 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.


Can easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).

The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.

Duke University 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 essential job 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.