Clinical Affairs Specialist

About the role

The Clinical Affairs Specialist will be responsible for supporting the development and execution of clinical projects within the organization. This role involves collaborating with cross-functional teams to ensure project success and compliance with regulatory standards.

Responsibilities

• Supports the planning and execution of clinical trials
• Collaborates with regulatory affairs, medical affairs, and other departments to ensure compliance with FDA and ICH guidelines
• Prepares and reviews documents related to clinical trials, including protocols, informed consent forms, and study reports
• Monitors and reports on clinical trial progress and issues
• Ensures adherence to Good Clinical Practice (GCP) guidelines

Requirements

• Bachelor's degree in a relevant field (e.g., Biomedical Sciences, Pharmacy, etc.)
• Minimum 2 years of experience in clinical research or related field
• Strong understanding of clinical trial processes and regulatory requirements
• Excellent communication and organizational skills
• Proficiency in Microsoft Office Suite

Qualifications

• Knowledge of Good Clinical Practice (GCP) guidelines
• Experience with electronic data capture systems (EDC)
• Ability to manage multiple projects simultaneously

Skills

• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team

Benefits

• Flexible remote work option
• Competitive compensation package
• Professional development opportunities
• Health insurance benefits

Pay

• $60,000 - $70,000 annually

Schedule

• Full-time position
• 40 hours per week