Actalent is hiring: Clinical Research Coordinator in Palo Alto

Contract to hire position based in Palo Alto, CA.

About the role

Onsite, 5 days per week. This role serves as the primary contact for research participants, sponsors, and regulatory agencies throughout the life cycle of oncology clinical trials.

Responsibilities

• Coordinate clinical research studies from start-up through close-out, ensuring all operational, regulatory, and data-related activities run smoothly.
• Determine participant eligibility according to study protocols and obtain informed consent in alignment with ethical and regulatory standards.
• Assist in developing and implementing effective participant recruitment strategies for oncology clinical trials.
• Coordinate the collection and processing of study specimens, ensuring proper handling, labeling, and documentation.
• Collect and manage patient and laboratory data for clinical research projects, maintaining accurate and timely records.
• Manage research project databases, including building and maintaining electronic data capture systems, developing flow sheets, and creating study-related documents.
• Complete study documents and case report forms accurately and on time, including entry into electronic data capture (EDC) systems.
• Ensure compliance with research protocols by reviewing and auditing case report forms for completeness and accuracy against source documents.
• Prepare and submit regulatory documents, including initial submissions and amendments, and ensure Institutional Review Board (IRB) renewals are completed on schedule.
• Assemble study kits for study visits, ensuring all required materials and documents are prepared in advance.
• Monitor scheduling of study procedures and related charges, coordinating with clinical teams to align visits and tests with protocol requirements.
• Coordinate and organize study documents and files, maintaining regulatory binders and essential documents in accordance with institutional and regulatory standards.
• Attend monitoring meetings with sponsors and contract research organizations, acting as the primary study contact and addressing questions related to study conduct and documentation.
• Monitor study expenditures and adherence to study budgets, collaborating with finance and management staff to resolve billing issues.
• Interact regularly with the principal investigator to review study progress, ensure patient safety, and confirm adherence to proper 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 monitoring visits and regulatory audits, providing requested documentation and supporting responses to findings.
• Perform chart reviews and pre-screen patients for eligibility, documenting findings and communicating with the study team.
• Work directly with patients in a hands-on capacity as part of gastrointestinal (GI) and oncology research activities, providing clear explanations of procedures and supporting a positive study experience.

Requirements

• 2 years of experience as a Clinical Research Coordinator (CRC), preferably with complex clinical trials.
• Hands-on experience working directly with patients in a clinical research setting, including GI and oncology populations.
• Experience with complex clinical trials, including multi-step protocols and intensive monitoring requirements.
• Proficiency with electronic data capture (EDC) systems for entering and managing study data.
• Experience performing chart reviews and pre-screening patients for clinical trial eligibility.
• Demonstrated ability to ensure compliance with research protocols and regulatory requirements, including IRB processes.
• Proven ability to manage research databases, case report forms, and study documentation accurately and efficiently.

Pay

The pay range for this position is $37.00 - $45.00 per hour. Individual compensation offered within this range will depend on qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Benefits

Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may include:

• Medical, dental, and vision insurance.
• Critical Illness, Accident, and Hospital coverage.
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available.
• Life Insurance (Voluntary Life & AD&D for the employee and dependents).
• Short and long-term disability.
• Health Spending Account (HSA).
• Transportation benefits.
• Employee Assistance Program.
• Time Off/Leave (PTO, Vacation or Sick Leave).

Schedule

Fully onsite position in Palo Alto, CA, 5 days per week.