Website RCERT Therapeutics Sdn Bhd
- Role summary: Provide operational, regulatory, and documentation support for interventional and procedural clinical trials in human therapeutics and medical-device-associated procedures.
- Key responsibilities: maintain Trial Master File and regulatory/consent documentation; support site activation, study start-up logistics, and investigator correspondence; track enrollment, adverse events, protocol deviations, and procedure-specific checklists; prepare monitoring visit packages, reconcile source documents and CRFs, and assist with query resolution; support safety reporting and compliance with ICH-GCP and applicable medical device or drug regulations; coordinate shipping/receipt of clinical samples and investigational products.
- Typical qualifications: Diploma or Degree in life sciences, nursing, clinical research, or related field; experience with clinical trials (pharma, device, or procedural studies) preferred; GCP/ICH certification desirable.
- Core skills: exceptional organization and documentation, knowledge of regulatory requirements for human therapeutics and procedures, proficiency with MS Office, attention to detail, and clear communication with clinical teams and regulators.
To apply for this job email your details to biokerjaya@bioeconomycorporation.my