Deskripsi Pekerjaan
Are you ready to shape the future of healthcare? BioPharma Nusantara is seeking a highly motivated Clinical Research Associate (CRA) to join our dynamic team in Medan, Sumatera Utara.
As a CRA, you will play a pivotal role in ensuring the integrity of our clinical trials and the safety of our patients. We are looking for an individual who thrives in a fast-paced environment and is committed to regulatory excellence.
Keunggulan Bergabung Bersama Kami:
- Proyek Clinical Trial internasional yang menantang.
- Fleksibilitas kerja dan lingkungan kerja profesional.
- Peluang pengembangan karir yang jelas.
- Memberikan dampak nyata pada pengembangan obat-obatan.
Tanggung Jawab
- Monitoring & Visits: Conduct regular on-site monitoring visits to clinical trial sites to ensure protocol compliance and data integrity.
- Regulatory Compliance: Ensure all trial activities comply with Good Clinical Practice (GCP) guidelines and local regulations.
- Data Management: Review Case Report Forms (CRFs) for accuracy and completeness before submission to the data management team.
- Adverse Event Reporting: Identify, document, and report any adverse events or serious adverse events (SAEs) according to timelines.
- Stakeholder Communication: Act as a primary liaison between the sponsor, investigators, and study sites.
- Site Initiation & Close-out: Participate in site initiation visits, monitoring visits, and close-out activities.
Kualifikasi
- Pendidikan: S1 Kedokteran, Farmasi, Keperawatan, atau Biologi dengan IPK minimal 3.00.
- Pengalaman: Pengalaman 1-3 tahun dalam Clinical Research atau fungsi terkait.
- Sertifikasi: Sertifikasi GCP (Good Clinical Practice) yang masih berlaku (wajib).
- Keahlian Komunikasi: Kemampuan komunikasi yang kuat dalam bahasa Indonesia dan Inggris (B2 level).
- Keahlian Organisasi: Kemampuan manajemen waktu dan prioritas yang baik.
- Lisensi: Memiliki SIM A (simulasi) adalah nilai tambah.