싱가폴 프레스티지파마에서 한국 근무할 CRA를 구합니다.
프레스티지는 FDA, EMA 그리고 KFDA에서 췌장암 희귀의약품지정을 받은 항체 신약을 한국에서 우선 임상 1상에 들어 가려고 준비 중입니다. 함께 1상 진행을 할 적극적인 분을 구합니다.
한국 서울에 주로 근무할 예정입니다.
효율적인 근무가 인정되면 파트타임도 가능하십니다.
연봉은 경력에 따라 협의가능입니다.
- Perform qualification, study initiation, routine monitoring and study close-out visits at investigating sites.
- Ensure the reported trial data are complete and the conduct of the trial follows the approved protocol, GCP, and regulatory requirements.
- Build collaboration and effective working relationships with internal teams and serve as the primary resource to the clinical investigator and site staffs.
- Ensure quality completion of site visit reports, follow-up letters, and maintenance of study-related databases.
- Assist Clinical Project Manager in trial management from study start-up to end of study.
- Assist in the TMF creation and maintenance.
- Liaise with Data-Management vendor to ensure generation of high-quality, reliable, and statistically sound data from a clinical study.
- Liaise with Central Laboratory, assist in bio-samples flow and reconciliation procedures.
- Assisting in logistic processes and IMP management among Sponsor, CMO, CROs and investigating sites.
- Contributing to development of clinical trial protocols, amendments, informed consent forms, study guidelines, case report forms and any other study related documents.
- Any other ad-hoc duty as assigned by supervisor or upper management.
- Degree in Life Science, Nursing, Pharmacy or equivalent.
- Minimum 1-2 years working experience in clinical research, pharmaceutical or CRO industries (preferred).
- Good knowledge of clinical trial processes and GCP requirements.
- Able to work as part of a team as well as achieve individually assigned tasks.
- Strong organizational skills and able to multi-task effectively.
- Good communication skills and must be proficient in English.
- Effective working with all levels within the company and third parties.
- Flexible, reliable and resilience.
- Proficient in MS Office, Teams.