Job Update: Senior Clinical Research Associate

Job Title: Senior Clinical Research Associate
Company: Iovance Biotherapeutics
Location: UK, Netherlands, or Switzerland (Remote)
Salary: Not specified
Contract Type: Full-time
Working Pattern: Remote, with up to 25% travel
Application Deadline: Not specified
Apply Here: Iovance Careers

About the Role

Iovance Biotherapeutics is seeking a Senior Clinical Research Associate (Sr. CRA) to oversee clinical trial sites, CROs, and study vendors while ensuring compliance with GCP guidelines, regulatory requirements, and company SOPs. The Sr. CRA will work closely with Clinical Trial Managers (CTMs), Study Directors, and Medical Monitors to drive operational excellence in Solid Tumor or Cell Therapy clinical trials.

Responsibilities

• Manage multi-center, US, and global clinical studies from start-up to close-out.
• Conduct on-site visits (feasibility, SIV, IMV, and close-out) alongside CRO CRAs.
• Monitor CRO activities, including scheduling, performance metrics, and reports.
• Ensure clinical site compliance with protocols, GCP/ICH guidelines, and SOPs.
• Oversee vendor management (e.g., Central Laboratory, Central Imaging, CROs).
• Perform in-house data reviews and regulatory documentation tracking.
• Support CTMs with contract negotiations, study logistics, and patient enrollment.
• Mentor junior clinical staff (e.g., Clinical Trial Assistants).
• Assist in developing protocols, informed consent documents, and case report forms (CRFs).
• Lead or support day-to-day clinical study operations.

Candidate Requirements

Must-Have Skills:

• BS/BA, RN, or equivalent with 4+ years of clinical trial monitoring/management.
• 4-8 years of Clinical Operations experience.
• Experience in Solid Tumor or Cell Therapy trials.
• Strong knowledge of ICH/GCP guidelines and clinical drug development processes.
• Expertise in managing CROs and study vendors.
• Excellent written and verbal communication skills in English.
• Proficiency in MS Word, Excel, PowerPoint, and Project.

Nice-to-Have Skills:

• Experience in early to late-phase clinical trials.
• Strong problem-solving and decision-making skills.

Travel

• Up to 25% travel required for on-site visits and vendor oversight.

Work Environment

• Remote role with occasional office visits as required.
• Standard office equipment usage.
• Must be able to remain stationary for prolonged periods.

Equal Opportunity Statement

Iovance Biotherapeutics is committed to fostering diversity and inclusion. We encourage applications from individuals of all backgrounds and provide reasonable accommodations for those who need them.

👉 Apply Now: Iovance Careers