Libo Pharma Corp. is a privately-held biopharmaceutical company focused on the development of novel protein therapeutics. As a NRDO (no research, development only) biopharmaceutical innovation incubator and hub, Libo extensively collaborates with global and regional partners and alliances to address unmet clinical and societal needs in Regenerative Medicine, Hematology, Oncology, Infectious Disease, and Immunology. It is our mission to contribute to medical advancement and to improve the quality of life for both patients and their families.
At Libo, we regard our team members as our most valuable assets, and are always seeking to enrich, expand and strengthen their knowledge and skillsets. As our US-based Senior CRA, you will actively oversee, lead, and monitor the progress of our various exciting regional and global clinical studies. You will report to the Chief Medical Officer/Clinical Operations Department at Libo Taiwan Headquarter, be part of an energetic, cross-functional team, and contribute to stimulating R&D discussions and strategic planning for Libo’s assets and pipelines.
Job Description
• Plans and manages clinical study budget and timeline.
• Executes and supports all clinical study-related tasks in compliance with GCP and applicable regulations.
• Serves as point of contact and maintain good communications with clinical study sites/IRB, CROs, central labs, and vendors/suppliers.
• Selects, oversees, and manages site, CRO, central lab, and vendor/supplier for clinical trials.
• Leads/participates in site visits, including site selection visits (SEV), site initiation visits (SIV), monitoring visits (co-monitoring; MV), site close-out visits (COV), or any other site visits or meetings with investigators, SC or other study team members; give brief presentations of IMP, protocol, study status, etc., when necessary.
• Participates and contributes in protocol development.
• Reviews and provides input to study-related documents and forms, such as ICF, CRF, CRF completion guideline, SAE report form, IMP accountability form, study monitoring plan, project management plan, etc.
• Reviews and edits study-related reports such as SEV, MV, SIV, COV reports.
• Reviews clinical study data (e.g. eCRF, questionnaire, patient diary, etc.) and SAE reports.
• Oversees IMP and central lab kit inventory/accountability and ensure timely supply.
• Maintains study-related documents and folders.
• Maintains/amend department SOP as necessary.
• Ability to drive and willingness to travel domestically and internationally up to 30%.

Qualifications
• Masters in Pharmacology or Pharmaceutical Sciences preferred, or relevant fields in Health Care or Biological Sciences.
• Prior 3-8 years of working experiences preferred.
• Prior wet lab experience (pharmacology or medical/biological sciences-related) is a must.
• Prior experiences in clinical trials is a must; prior experiences in global trial preferred.
Desired Qualities
• Strong self-learning abilities and highly motivated to learn new skills.
• Able to work both independently and as part of a team.
• Able to multi-task and support cross-functional team when necessary.
• Bilingual: English and Mandarin Chinese; knowledge of Japanese is a plus.
Please provide a cover letter and CV in English.