Clinical Research Associate - Remote Position

About the Role

We are seeking a dedicated Clinical Research Associate (CRA) to join our team at Novotech. This Clinical Research Associate remote position is crucial in ensuring the rights and well-being of trial participants are protected while guaranteeing the accuracy and completeness of reported trial data. As a CRA, you will serve as the primary contact between Investigational Sites, Novotech, and the Sponsor, ensuring that clinical trials are conducted in accordance with ICH GCP guidelines and regulatory requirements.

What You'll Do

• Build and maintain relationships with Principal Investigators, study coordinators, and site trial personnel to facilitate efficient clinical trial management.
• Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA) to prepare essential site documents and support ethics and regulatory submissions.
• Drive participant recruitment initiatives and develop site-specific recruitment plans to meet targets.
• Conduct monitoring visits as per ICH GCP and the Clinical Monitoring Plan (CMP), ensuring compliance with protocols and participant safety.
• Verify the accuracy and completeness of trial data, ensuring timely resolution of queries in accordance with study timelines.
• Ensure proper storage, dispensing, and reconciliation of study drugs as outlined in the Clinical Monitoring Plan.

Requirements

• A graduate degree in a clinical or life sciences-related field.
• 2-3 years of relevant experience as a Clinical Research Associate in the clinical industry.
• Strong time management skills and attention to detail.
• Excellent interpersonal and teamwork skills, with a commitment to innovative treatment development.
• Proficiency in computer applications relevant to clinical research.

Nice to Have

• Experience in the pharmaceutical industry or related fields.
• Knowledge of local and international regulatory requirements.
• Experience with remote monitoring visits.

What We Offer

• Flexible working options to support work-life balance.
• Paid parental leave for both parents.
• Wellness programs and ongoing professional development opportunities.
• A diverse and inclusive work environment.
• Access to mentorship and career growth opportunities.