Job Description
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 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.
Contribute 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%.
THE QUALIFICATIONS
BA/BS in equivalent field or equivalent years of experience.
2 or more years of sponsor company experience.
Experience working within international multi-site studies is a plus.
Experience working with CROs 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.
SALARY & LEVEL
89bio considers a range of factors when determining the salary and level. These considerations mean actual salary and level may vary. The salary range for this position is $130,000 - $150,000 and will be commensurate with experience.
THE PERKS
Competitive health insurance coverage
Generous PTO allowance
401k match
Employee Stock Purchase Plan (ESPP)
Commuter Benefits
Women's forum / mentoring
Office based in the heart of San Francisco, near plenty of shops and restaurants
Fun opportunities to engage with co-workers in-person and remotely
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Proof of Covid vaccination is a condition of employment.
Notice to Recruiters: To protect the interest of all parties, 89bio does not accept unsolicited resumes and we ask that employees, hiring managers and executives not be contacted directly. All recruitment is managed through the 89bio Talent Acquisition Team.
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#J-18808-Ljbffr San Francisco
Job Tags
Interim role, Remote job,