Clinical Research Specialist, Senior - Duke Cancer institute

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.

Be You.

The Duke Cancer Institute (DCI) is seeking a Clinical Research Specialist, Sr. to join the Bone Marrow Transplant, Hematologic Malignancies, and Cellular Therapy Clinical Research Program. In this vital role, you will serve as a data coordinator supporting innovative cell therapy clinical trials that help advance groundbreaking cancer treatments and improve patient outcomes.

As a member of the Oncology Clinical Research Unit (CRU), you will play an important role in the daily management of clinical research studies, supporting the collection, documentation, quality review, and maintenance of critical clinical trial data. You will work closely with research participants, study teams, principal investigators, sponsors, and regulatory personnel to ensure research activities are conducted accurately, ethically, and in compliance with institutional, federal, and sponsor requirements.

This position offers an opportunity to develop expertise in clinical research operations, data management, participant coordination, and regulatory compliance while contributing to cutting-edge clinical trials in cellular therapy and hematologic malignancies. Your work will directly support research efforts that advance scientific discovery and improve patient care.

Minimum Requirements

• Associate's degree.
• One year of relevant experience.
• Completion of the DOCR North Carolina State Approved Clinical Research Pre-Apprenticeship Program may substitute for one year of required experience.
• Ability to effectively use computer software and web-based applications, including Microsoft Office products and internet browsers.

Preferred Qualifications

• Bachelor's degree strongly preferred.
• Experience supporting clinical research studies, clinical trials, healthcare operations, research data management, or related activities.
• Experience entering and managing data within Electronic Data Capture (EDC) systems.
• Knowledge of clinical research regulations, Good Clinical Practice (GCP), human subject protections, and Institutional Review Board (IRB) requirements.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication skills.
• Ability to identify, investigate, and resolve data discrepancies independently.
• Experience working in oncology, hematology, bone marrow transplant, cellular therapy, or related clinical research environments preferred.

Other Requirements

• Maintain all required Duke and project-specific clinical research training and certifications.
• Adhere to all institutional, regulatory, sponsor, and protocol-specific requirements governing clinical research.
• Participate in monitoring visits, audits, and research-related training activities as required.

Be Bold.

Position Description:

As a Clinical Research Specialist, Sr., you will support the conduct of clinical research studies through participant coordination, study management, data collection, quality review, and regulatory compliance activities.

Coordinate Clinical Research Operations

• Support day-to-day study operations for cellular therapy, bone marrow transplant, and hematologic malignancy research studies.
• Recruit and screen research participants according to protocol requirements and established standard operating procedures.
• Schedule participant research visits and prepare study materials, equipment, supplies, and documentation required for protocol activities.
• Conduct and document minimal-risk study visits, scripted interviews, questionnaires, and research activities as permitted by protocol and institutional guidelines.
• Maintain participant-level and study-level documentation to support regulatory compliance and study conduct.
• Participate in study team meetings and assist with implementation of protocol-specific workflows and processes.
• Prepare studies for monitoring visits, audits, site visits, and study closeout activities.
• Communicate effectively with sponsors, contract research organizations (CROs), investigators, and research team members.

Manage and Maintain Clinical Research Data

• Enter, review, and maintain study data within Electronic Data Capture (EDC) systems and other research databases.
• Complete paper and electronic Case Report Forms (CRFs and eCRFs) accurately and within required timelines.
• Generate reports, summaries, and study-related documentation using clinical research systems.
• Independently investigate, reconcile, and document incomplete, inaccurate, inconsistent, or missing research data.
• Follow established quality assurance procedures and standard operating procedures to ensure data quality and integrity.
• Maintain compliance with data security, confidentiality, data provenance, and data-sharing requirements.
• Support data preparation activities including data cleaning, dataset merging, variable recoding, score recalculation, and database validation under appropriate supervision.
• Assist with preparation of tables, summaries, data visualizations, and participant-friendly study result communications.

Support Regulatory and Compliance Activities

• Apply knowledge of institutional, regulatory, and protocol requirements to clinical research activities.
• Assist with protocol submissions, regulatory documentation, consent materials, and study-related records.
• Conduct and document informed consent activities for approved minimal-risk studies.
• Assist with preparation of documentation for sponsor reporting, safety reporting, and regulatory submissions.
• Recognize and report protocol-defined adverse events and participant safety concerns to the study team.
• Ensure studies are conducted in accordance with Good Clinical Practice, IRB requirements, sponsor expectations, and Duke policies.

Collaborate and Communicate Effectively

• Serve as a resource for routine study-related questions and direct complex issues to appropriate team members.
• Coordinate with investigators, research nurses, regulatory coordinators, data managers, sponsors, and other stakeholders to support successful study implementation.
• Maintain professional relationships while contributing to efficient problem-solving and study execution.
• Demonstrate adaptability and resilience in a dynamic research environment.

Contribute to Professional Development and Team Success

• Participate in ongoing training and professional development opportunities.
• Stay current with clinical research regulations, technologies, and best practices.
• Attend departmental and institutional research education programs and meetings.
• Share knowledge and provide training support to colleagues when appropriate.
• Demonstrate organizational awareness and effective collaboration across Duke clinical research operations.

Choose Duke.

At Duke Cancer Institute, you'll be part of one of the nation's leading comprehensive cancer centers, where researchers, clinicians, and staff work together to advance innovative therapies and improve outcomes for patients facing cancer and blood disorders. Through groundbreaking clinical trials and translational research, the Bone Marrow Transplant, Hematologic Malignancies, and Cellular Therapy Program is helping shape the future of cancer treatment.

Join a collaborative environment that values excellence, discovery, innovation, and professional growth. You'll have the opportunity to work alongside world-class physicians, scientists, and research professionals while contributing to studies that bring new therapies and hope to patients.