Hybrid Thoracic Oncology Clinical Research Coordinator

ACTalent; United States; Hybrid; USD 41,000 - 43,000; Full time

Job summary

Actalent is seeking a Clinical Research Coordinator (Thoracic) to manage oncology studies in a hybrid Palo Alto setting, coordinating start-up through closeout under PI or senior supervision. The role emphasizes patient safety, data integrity, and regulatory compliance within a dynamic research environment.

Ideal candidates bring oncology research experience, EPIC/EMR proficiency, IRB familiarity, and strong organizational and communication skills to support sponsor interactions and study

Qualifications

• Two-year college degree and two years of related clinical research or healthcare experience.
• Hands-on experience as an onsite clinical research coordinator, including coordination of treatment trials.
• Demonstrated experience in oncology clinical research, preferably thoracic oncology.
• Proficiency in chart review and extraction of relevant clinical information from medical records.
• Clinical research assistant and data entry experience, with strong attention to detail and accuracy.

Responsibilities

• Serve as the primary point of contact for research participants, sponsors, and regulatory agencies, providing clear communication and timely updates throughout the study lifecycle.
• Coordinate one or more moderately complex clinical studies from initiation through closeout, following established protocols and institutional guidelines.
• Determine participant eligibility according to study protocol and facilitate the informed consent process, ensuring participants understand study procedures and requirements.
• Assist in developing and implementing recruitment strategies to identify and enroll appropriate study participants.
• Coordinate the collection and processing of study specimens, ensuring proper handling, labeling, and documentation in accordance with protocol and regulatory standards.
• Collect, enter, and manage patient and laboratory data for clinical research projects, maintaining accurate and complete records.
• Manage research project databases, including creating and maintaining flow sheets, logs, and other study-related documents, and completing case report forms in a timely manner.
• Review and audit case report forms for completeness and accuracy against source documents, correcting discrepancies and maintaining high data quality.
• Ensure strict compliance with research protocols, institutional policies, and regulatory requirements throughout the duration of each study.
• Prepare and submit regulatory documents, including Institutional Review Board (IRB) applications and renewals, ensuring all approvals and continuing reviews are completed on schedule.
• Assemble study kits for study visits, organize study materials, and monitor scheduling of procedures and related charges to support smooth study operations.
• Coordinate and maintain study documentation, attend monitoring meetings with sponsors, and act as the primary contact for sponsor monitors.
• Monitor study expenditures and adherence to study budgets, identify and resolve billing issues in collaboration with finance and/or management staff.
• Interact regularly with the principal investigator to report on study progress, discuss issues, and ensure patient safety and appropriate study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files and systems in line with institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits, supporting preparation, responding to queries, and implementing any required corrective actions.

Skills

Two-year college degree

Clinical research experience

Onsite CRC experience

Thoracic oncology experience

EPIC EMR

Data entry

Regulatory knowledge IRB

Study logistics coordination

Strong communication

Attention to detail

Job description

Actalent is seeking a Clinical Research Coordinator (Thoracic) to manage oncology studies in a hybrid Palo Alto setting, coordinating start-up through closeout under PI or senior supervision. The role emphasizes patient safety, data integrity, and regulatory compliance within a dynamic research environment.

Ideal candidates bring oncology research experience, EPIC/EMR proficiency, IRB familiarity, and strong organizational and communication skills to support sponsor interactions and study