Job Description
We are seeking a Senior Clinical Research Associate (CRA) to join our elite team in Singapore. If you are passionate about accelerating drug development and ensuring the highest standards of patient safety, this is your opportunity to make a tangible impact on global healthcare.
At ApexBio Solutions, we are dedicated to transforming patient lives through innovative science. We foster a dynamic, collaborative culture where your expertise is valued, and your career can thrive.
What You Will Do
As a Senior CRA, you will play a pivotal role in the clinical trial lifecycle, ensuring compliance, data integrity, and successful trial execution.
Responsibilities
- Oversee clinical trial monitoring activities to ensure full compliance with Good Clinical Practice (GCP) and regulatory standards.
- Manage relationships with Principal Investigators (PIs), study coordinators, and site staff to ensure smooth trial operations.
- Monitor data collection, ensuring accuracy, timeliness, and integrity throughout the trial lifecycle.
- Identify, assess, and mitigate clinical trial risks and deviations proactively.
- Prepare and submit accurate regulatory documentation to Health Authorities.
- Lead training sessions for site staff regarding trial protocols and GCP requirements.
- Conduct site initiation and close-out visits as required.
Qualifications
- Bachelor’s degree in Pharmacy, Medicine, Nursing, Life Sciences, or a related field.
- Valid GCP certification (e.g., ICR-CH, ICH-E6 R2) is mandatory.
- Minimum 3-5 years of experience as a Clinical Research Associate in the pharmaceutical or biotechnology industry.
- Proven experience managing multi-site clinical trials and complex study protocols.
- Strong understanding of drug development processes, regulatory affairs, and trial management systems (CTMS).
- Excellent communication, negotiation, and interpersonal skills.
- Ability to travel up to 50% as required for site monitoring.