Clinical Research Associate/ Senior Clinical Research Associate

at  89bio

THE COMPANY

89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardio-metabolic diseases. The company’s lead product candidate, pegozafermin (BIO89-100), is a specifically engineered glycoPEGylated analog of FGF21. Pegozafermin is being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).

THE QUALIFICATIONS

• BA/BS in equivalent field.
• 2 or more years of relevant experience.
• Experience working within international multi-site studies is a plus.
• Experience working with CRO’s is preferred.
• Excellent interpersonal, organizational, problem-solving, and written/verbal communication/influence skills.
• Proficiency in MS Word/Excel/Project.
• Experience with electronic data capture/reviewing/interpreting data desired.

THE ROLE

The Clinical Research Associate/Senior Clinical Research Associate will participate in planning and assisting in overseeing the conduct of clinical trials in accordance with Company policies and procedures and applicable regulations.

THE RESPONSIBILITIES

• Participate in all aspects of assigned clinical studies to ensure studies are completed on time, within budget, and in compliance with FDA regulations and ICH/GCP guidelines.
• Participate in the design and development of clinical trial protocols and case report forms.
• Contribute to the development of study-specific documents, e.g., study guides, tools, and informed consents.
• Contribute to the clinical section of the study protocol and assist in document reviews.
• Chair or participate in meetings or conference calls with multi-disciplinary study team, regional monitors, or vendors (e.g., CROs, central Labs).
• Involved in the management of CROs, central labs, core labs, drug distribution center, and regional monitors.
• Assist with the review of clinical site budgets.
• Participate in providing guidelines for assessing the adequacy of potential clinical investigators and sites: including evaluating facilities, personnel, patient referral base, and adherence to Good Clinical Practices (GCP).
• For Company-based studies, participate in clinical study monitoring priorities and assist in writing monitoring plans; evaluate these activities when conducted by CRO.
• Contributes to GCP inspection-readiness activities.
• Assist with the preparation of safety, interim and final study reports, and resolution of data discrepancies.
• Travel up to 25%.