프레스티지 바이오파마 CRA 모집

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.

Job Description

• 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.

Job Requirements:

• 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.