What are the responsibilities and job description for the Senior Clinical Research Associate position at 89Bio?
THE COMPANY
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through Phase 3 clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco.
THE ROLE
Reporting to the Senior Clinical Trial Manager, the 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.
SPECIAL ADVISORY
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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 management of CROs, labs, and other vendors.
- Provide oversight of sites and/or regions.
- Contribute to the development and review of study-specific documents, e.g., clinical trial protocol, study guides, tools, and informed consents.
- Review monitoring visit reports and protocol deviations.
- Assist in the preparation of regulatory or ethics submissions.
- Lead or participate in meetings or conference calls with multi-disciplinary study team, regional monitors, or vendors.
- Assist with the review of vendor or clinical site budgets.
- Assist in or lead the setup of study vendors as needed.
- Contribute to regulatory inspection-readiness activities.
- Assist with the preparation of safety, interim and final study reports, and resolution of data discrepancies.
- Attend site visits, e.g. study initiation, interim monitoring, and engagement.
- Travel up to 25%.
- Other duties as assigned.
THE QUALIFICATIONS
- BA/BS degree in science or health related field or equivalent years of experience.
- 4 or more years of Sponsor, CRO, or site experience (Senior Clinical Research Associate)
- Experience working with CROs (or at a CRO).
- Experience working at a clinical research site is a plus.
- Experience working within international studies is a plus.
- Excellent interpersonal, organizational, problem-solving, and written/verbal communication/influence skills.
- Proficiency in MS Word/Excel/Powerpoint/Outlook.
SALARY & LEVEL
89bio considers a range of factors when determining salary and level. These considerations mean actual salary and level may vary. The expected salary range for this position based on the primary location for this position in Northern California is $130,000 - $150,000.
89bio’s role/level assessment approach involves assessing candidates during the interview process before confirming the level/title designation. The level assessment is considered on a case-by-case basis. Offer and level is based on factors such as:
education, experience, qualifications, geographic location, transferable skills, licenses/certifications and other job-related factors permitted by law.
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
CONDITIONS OF EMPLOYMENT
- Background investigations are required for all positions by 89bio, consistent with applicable law.
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.
89bio is committed to the full inclusion of all qualified individuals. As part of this commitment, 89bo will ensure that persons with disabilities are provided reasonable accommodations for the hiring process, and/or to perform essential job functions where the requested accommodation does not impose an undue hardship.
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.
Salary : $130,000 - $150,000
