Clinical Trial Specialist

About the role

This role offers the opportunity to contribute to a leading National Cancer Institute–designated Comprehensive Cancer Center that delivers advanced cancer care to adults and children while conducting cutting-edge oncology research.

Responsibilities

• Cover initiation and activation of new clinical trial protocols, ensuring all required approvals and documentation are in place prior to study activation.
• Verify Scientific Review Board, Institutional Review Board, Human Research Oversight Committee approvals, data collection plans, and finance/contract approvals before opening a study to enrollment.
• Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets to support accurate and compliant trial conduct.
• Use clinical trials software and Microsoft Excel and Word to develop, maintain, and update study tools and tracking documents.
• Collaborate with Research Nurse Clinicians and physicians to review patient charts and medical histories, confirm protocol eligibility, and obtain required source documents from the medical record.
• Ensure that IRB-approved informed consent is obtained in accordance with regulatory and institutional requirements, including confirming signatures, filing consent forms in the medical record, and providing copies to patients.
• Register consented research participants with study sponsors, including industry partners and NCI cooperative groups, and enter participant data into the clinical trials database.
• Maintain complete and accurate research records for all patients enrolled on clinical trials, including consent forms, eligibility documentation, case report forms, registration confirmations, and corresponding source documents.
• Serve as a primary liaison with study sponsors, coordinating monitoring visits, conference calls, and ongoing communications throughout the life of each study.
• Provide timely, accurate, and well-supported responses to sponsor queries and anticipate sponsor needs to maintain strong collaborative relationships.
• Assist Research Nurse Clinicians and physicians in grading adverse events using the latest National Cancer Institute common toxicity criteria or protocol-specific grading scales.
• Complete Serious/Unexpected Adverse Event forms for internal and multicenter events in accordance with sponsor requirements, federal regulations, and institutional policies.
• Monitor research records regularly to ensure they remain current, accurate, and audit-ready for all assigned clinical trials.
• Generate regular reports from the clinical trials database for tumor study group members and Principal Investigators, summarizing enrollment, status, and key trial metrics.
• Coordinate day-to-day study operations, including scheduling study visits, tracking required assessments, and ensuring adherence to protocol timelines.
• Communicate effectively with patients, clinical teams, and research staff to clarify procedures, explain study requirements, and support participant engagement and retention.
• Contribute to continuous improvement of clinical research processes by maintaining high professional standards, maximizing available resources, and supporting quality assurance activities.

Qualifications

• Bachelor’s degree required.
• Two to four years of relevant clinical research experience, preferably in oncology.
• Experience as a Clinical Research Coordinator or in a closely related clinical research role.
• Demonstrated experience in recruitment, screening, enrollment, and consenting of patients for clinical research studies.
• Hands-on experience with oncology clinical research studies and pharmaceutical drug trials.
• Solid knowledge of computer software programs, including Microsoft Excel, Word, and Access.
• Experience using clinical trials databases and electronic health record systems such as Epic.
• Strong understanding of informed consent processes, source documentation requirements, and regulatory expectations in clinical research.
• Comfort communicating with patients, clinicians, and research teams about study procedures, consent, and documentation.
• Ability to interpret and apply National Cancer Institute common toxicity criteria or protocol-specific adverse event grading scales.
• Excellent attention to detail and accuracy in documentation and data entry.
• Strong organizational skills with the ability to manage multiple trials, tasks, and timelines simultaneously.
• Effective written and verbal communication skills for interacting with patients, investigators, sponsors, and internal teams.
• Ability to work collaboratively in a multidisciplinary environment and support Good Clinical Practice standards.