Clinical Affairs Specialist

Job Summary

The full-time Clinical Affairs Specialist will support the execution of clinical studies for product development and regulatory submissions, ensuring compliance with regulatory requirements and project timelines while collaborating with internal and external stakeholders in a remote work environment.

Key Responsibilities:

• Support day-to-day activities for clinical studies from planning through reporting and close-out under project leadership
• Collaborate with internal stakeholders, CROs, and clinical sites to ensure study execution aligns with protocols and regulations
• Maintain study documentation and support data review, issue resolution, and regulatory activities related to clinical studies

Required Qualifications:

• Bachelor's degree in life sciences or a related field
• 2+ years of experience in clinical affairs, clinical research, or regulatory affairs, preferably in the medical device industry
• Strong understanding of GCP, ICH guidelines, and applicable regulatory requirements
• Experience working with vendors, sites, and cross-functional teams
• Basic understanding of clinical data analysis and issue resolution