Lead clinical trial excellence at investigative sites worldwide. Emerald Clinical Trials seeks an experienced Senior Clinical Research Associate to manage site operations for our global clinical trials. In this pivotal role, you will coordinate site selection, monitoring activities, and regulatory compliance while mentoring junior staff and ensuring the highest standards of data quality and patient safety across our renal, cardiometabolic, and oncology research programs.
Key Responsibilities
You will be the primary point of contact for clinical trial sites, ensuring operational excellence and regulatory compliance throughout the trial lifecycle.
Site Management & Monitoring:
- Coordinate site identification, feasibility assessment, and selection processes
- Conduct comprehensive monitoring visits (evaluation, initiation, routine, close-out) per Monitoring Plan requirements
- Verify data quality, accuracy, and timeliness while ensuring efficient resolution of data queries
- Manage investigational product distribution, tracking, and destruction per trial requirements
Regulatory & Compliance:
- Prepare and submit regulatory packages to Ethics Committees and health authorities
- Ensure adherence to ICH/GCP guidelines and company SOPs
- Collect, review, and approve essential documents for Trial Master File (TMF) compliance
- Report safety events, protocol violations, and mitigate identified risks
Operational Leadership:
- Negotiate site budgets and contracts, tracking invoicing and payments
- Develop monitoring tools and project-specific documents
- Mentor, coach, and train junior clinical staff members
- Implement strategies to enhance patient recruitment and site performance
Your Skills and Experience
Essential Qualifications:
- Degree in Pharmacy, Medicine, Nursing, Biological Sciences or related health field
- 4-5+ years of clinical trial monitoring and site management experience
- Comprehensive knowledge of ICH/GCP guidelines and regulatory requirements
- Experience in CRO, pharmaceutical, or academic research environments
Required Competencies:
- Expertise in site start-up, conduct management, and quality oversight
- Strong negotiation, conflict resolution, and problem-solving skills
- Excellent interpersonal and communication abilities
- Strategic thinking with ability to work autonomously and within teams
Why Join Emerald Clinical Trials?
We offer more than a job—we offer a career with purpose:
- Meaningful Impact: Contribute to life-changing therapies in critical therapeutic areas
- Professional Growth: Mentorship opportunities and global career development
- Collaborative Culture: Work with diverse, passionate professionals worldwide
- Competitive Package: Comprehensive benefits and recognition programs
Ready to advance clinical research while developing your career? Apply now to join our team dedicated to improving global health outcomes.
We are an equal-opportunity employer committed to diversity and inclusion.
