Clinical Research Coordinator

Be You. Be Bold. Choose Duke.

Be You.

Participates in or leads day to day operations of clinical research studies conducted by Principal Investigator(s) (PI) at Duke Health; performs 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.

Be Bold.

Research Operations

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. May prepare Food and 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 potential hold issues in collaboration with the PI. Knowledgeable in regulatory and institutional policies and processes; applies knowledge appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs). 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 or unblinding. May maintain study level documentation for international studies and develop resources and tools for management of international studies, and coordinate with other entities or offices. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. Maintains all participant and study level documentation for studies that are greater than minimal risk or complex in nature (e.g., procedural and interventional studies). Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems. Escalates issues. Screens participants for greater than minimal risk or complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs. Collects, prepares, processes, ships, and maintains the inventory of human research specimens,primarily those requiring complex procedures. 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.

Safety and Ethics

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. Conducts and documents consent for participants for all types of studies, including those that are greater than minimal risk or complex in nature and require any orders in Maestro Care. Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation for Institutional Review Board (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. Responsible for adherence to clinical research policies to ensure ethical conduct and protection of vulnerable populations. Communicates the difference between clinical activities and research activities, and the risks and benefits of study participation to research participants.

Data

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, 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 (QA) 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 protocol data workflow including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). Demonstrates and applies open science practices and the FAIR data principals. 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 reuse. Innovatively uses technology to enhance a research process. 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. May conduct rapid and in depth qualitative analyses or use statistical tools (e.g. SAS, R, SPSS) to perform statistical analysis. May code quantitative data using statistical tools to prepare for analysis under direct supervision from Biostatistician and PI or critically examine and interpret qualitative, unstructured and semi structured data, and rigorously explain findings in relation to the research context; includes the use of qualitative data analysis software (e.g., NVivo, Atlas.ti) to code and categorize the data.

Scientific Concepts

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 and serves as an author on poster presentations or publications.

Site and Study Management

Prepares for, coordinates, and actively participates in sitevisits. Communicates effectively with sponsors and contract research organizations (CROs). Uses clinical research management system and its reports to manage research participants activities, calendars, tracking and marking of financial milestones, and all aspects of study visits. Uses required EHR functionalities to manage participants and study visits. Uses OnCore and eREG systems and system reports to manage research protocols. Collects appropriate information to determine whether the study teams 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. Ensures that studies areconducted 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). 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. May serve on committees and workgroups internal to Duke or externally in therapeutic area of research. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. 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.

Knowledge, Skills and Abilities

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

Level Characteristics

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

Minimum Qualifications

Education

Completion of an Associate's degree

Experience

Work requires a minimum of two years of relevant research experience. Completionof the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience.

Degrees, Licensures, Certifications

Work requires a minimum of two years of relevant research experience. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience.

Choose Duke.

At Duke Health, you will be part of a collaborative and innovative clinical research environment committed to advancing discoveries that improve patient care and outcomes.

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