CLINICAL RESEARCH COORDINATOR

Duke Careers•Durham, NC

About The Position

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations. Be You. Be Bold. Choose Duke. Be You. At Duke we celebrate individuality, rigor, and the impact of meaningful clinical research. As a Clinical Research Professional supporting Duke Principal Investigators, you will participate in or lead the day-to-day operations of clinical research studies. You will perform a wide range of duties related to the collection, compilation, documentation, and analysis of clinical research data, while collaborating across multidisciplinary teams and supporting complex and greater-than-minimal-risk research.

Requirements

Ability to use computing software and web-based applications including Microsoft Office and internet browsers.
Associate’s degree required.
Minimum of two years of relevant research experience. Completion of the DOCR NC state-approved Clinical Research Apprenticeship Program may substitute for one year of experience.

Responsibilities

Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
May prepare FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation.
Addresses FDA review and potential hold issues in collaboration with the PI.
Applies regulatory and institutional policy knowledge to study documentation, protocol submissions, and SOPs.
Responsible for all aspects of investigational product (IP) management including arrival, storage, tracking, and provision to participants.
Serves as the primary liaison with sponsors, IDS, and other stakeholders.
Follows protocol schema for randomization, blinding, and unblinding.
Maintains documentation for international studies and coordinates with internal and external entities.
Prepares for and supports monitoring and audit visits and addresses findings.
Maintains participant- and study-level documentation for greater-than-minimal-risk and complex studies.
Develops recruitment and retention strategies and escalates issues.
Screens participants for complex and greater-than-minimal-risk studies.
Develops or contributes to SOPs.
Collects, processes, ships, and inventories human research specimens requiring complex procedures.
Conducts protocol-compliant study visit activities.
Facilitates and may lead multidisciplinary meetings.
Identifies adverse events and determines reportability.
Collaborates with the PI to assess AE attributes including relatedness.
Conducts and documents informed consent for all study types, including those requiring Maestro Care orders.
Develops consent plans and documents.
Prepares and submits IRB documentation via iRIS and communicates with IRB staff.
Prepares and submits regulatory and safety reports to sponsors and agencies.
Ensures ethical conduct of research and protection of vulnerable populations.
Explains differences between clinical care and research and communicates risks and benefits to participants.
Collects and enters data and develops data collection SOPs and tools.
Provides oversight and training for data collection and entry.
Ensures data accuracy and completeness.
Identifies data quality trends and escalates issues.
Develops QA tools and procedures.
Recognizes and reports data security vulnerabilities.
Develops or reviews data lifecycle and management plans.
Maps protocol data workflows across systems including EDCs, EHRs, and mobile apps.
Applies FAIR data principles and open science practices.
Prepares data for repository submission and sharing.
Drafts data sharing plans.
Uses technology to enhance research processes.
Creates tables, visualizations, reports, and lay summaries.
Conducts qualitative and quantitative analyses using tools such as SAS, R, SPSS, NVivo, or Atlas.ti under appropriate supervision.
Assists with funding proposals.
Conducts independent literature searches and reviews.
Develops protocol elements.
Demonstrates understanding of research study design.
Contributes to publications and presentations and may serve as an author.
Coordinates and participates in site visits.
Communicates with sponsors and CROs.
Uses clinical research management systems, OnCore, eREG, and EHR tools.
Assesses study feasibility and makes recommendations.
Ensures supplies and equipment readiness.
Forecasts effort needs.
Ensures compliance with institutional policies.
Implements operational plans.
Prepares studies for closeout and document storage.
Trains and oversees others.
Pursues ongoing professional development.
Disseminates knowledge.
Serves on committees and workgroups.
Demonstrates organizational awareness, resilience, adaptability, and advanced subject matter expertise.
Communicates effectively across reporting relationships.

Benefits

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.

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