Deskripsi Pekerjaan
Peregrine Eye and Laser Institute is a premier facility dedicated to advancing medical science and improving patient outcomes through innovative eye care and aesthetic treatments. We are currently seeking a highly organized and detail-oriented Clinical Research Coordinator (CRC) to join our dynamic research team. In this key role, you will be responsible for the overall management of clinical trials, ensuring that all research activities are conducted in strict accordance with Good Clinical Practice (GCP) guidelines and local regulatory standards. You will serve as the primary liaison between the study team, sponsors, and participants, playing a vital role in the successful execution of our clinical protocols in the field of ophthalmology and vision correction.
As a Clinical Research Coordinator at Peregrine, you will oversee the daily operations of the study site, from protocol initiation and patient recruitment to data management and final study close-out. We are looking for a candidate who is passionate about medical research, possesses excellent communication skills, and thrives in a fast-paced, collaborative environment. Join us in our mission to bring cutting-edge therapies to patients in the Philippines.
Tanggung Jawab
- Manage the end-to-end lifecycle of clinical trials, including IRB/IEC submissions, protocol development, and study close-out documentation.
- Coordinate patient recruitment, screening, and enrollment activities to meet study milestones and target enrollment numbers.
- Conduct regular site visits to monitor patient visits, ensure data integrity, and verify adherence to the study protocol.
- Ensure strict compliance with Good Clinical Practice (GCP), ICH-GCP, and local regulatory requirements throughout the study.
- Maintain accurate and timely data entry into electronic data capture (EDC) systems and ensure all source documents are properly documented and stored.
- Communicate effectively with sponsors, investigators, and regulatory bodies to resolve queries, discrepancies, and study-related issues.
- Monitor study budgets, track study expenses, and ensure proper procurement of study materials.
Kualifikasi
- Bachelor’s degree in Nursing, Biology, Pharmacy, or a related scientific field is required; a Master’s degree is a plus.
- Current RN license or at least 1-2 years of relevant experience in clinical research coordination within the healthcare or medical device industry.
- Comprehensive knowledge of Good Clinical Practice (GCP) guidelines and regulatory affairs.
- Strong organizational skills with the ability to multitask and prioritize multiple clinical trials simultaneously.
- Excellent interpersonal and communication skills, with the ability to interact professionally with patients, medical staff, and external stakeholders.
- Proficiency in Microsoft Office Suite and electronic data capture systems (e.g., REDCap, Medidata Rave).
- Ability to travel within Metro Manila for site visits as needed.