Deskripsi Pekerjaan
We are looking for a dedicated and organized IRB Secretary to support the research operations at Peregrine Eye and Laser Institute. As a leading provider of eye care and laser treatments, we are committed to maintaining the highest standards of clinical research ethics and compliance. In this pivotal role, you will assist the Institutional Review Board (IRB) in the review and approval of clinical protocols, ensuring that all research activities adhere to local regulations and international guidelines.
The ideal candidate will excel in a fast-paced medical environment, demonstrating exceptional written and verbal communication skills. You will serve as the primary point of contact for researchers and medical personnel, managing the lifecycle of research documentation from submission to approval. If you have a keen eye for detail and a passion for research administration, we invite you to join our team.
Tanggung Jawab
- Coordinate and schedule regular IRB meetings, ensuring all materials are distributed to committee members in advance.
- Prepare comprehensive meeting packets, including protocols, consent forms, and amendments for review.
- Take accurate minutes during meetings and circulate them for review and approval within 48 hours.
- Maintain the IRB master file and ensure all documentation is organized, secure, and up-to-date.
- Liaise with Principal Investigators (PIs) and medical staff to clarify protocol details and gather necessary documentation.
- Monitor ongoing research protocols for compliance with ethical standards and Good Clinical Practice (GCP).
- Assist in the preparation of annual reports and statistical summaries for the IRB committee.
Kualifikasi
- Bachelor’s degree in Medical Technology, Nursing, Pharmacy, or a related scientific field.
- Minimum of 2-3 years of experience in research administration, medical writing, or clinical operations.
- Strong understanding of Good Clinical Practice (GCP) and regulatory compliance requirements.
- Excellent oral and written communication skills with the ability to communicate effectively with medical personnel.
- Proficient in Microsoft Office Suite (Excel, Word, PowerPoint) and document management software.
- High level of attention to detail and the ability to manage multiple priorities in a dynamic setting.
- Strong organizational skills with a commitment to accuracy in documentation.