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.