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
Reporting to our Associate Director of Clinical Operations, the Clinical Trial Associate will participate in planning and assisting in managing the conduct of clinical trials in accordance with company policies and procedures and applicable regulations. The role may include some travel when conditions allow.
THE RESPONSIBILITIES
- Prepares and maintains documents and files such as clinical study files, regulatory binders, and operations manuals for clinical sites (i.e., investigators 1572s, informed consent form, protocol and investigators brochure).
- Under general supervision collects, processes and tracks investigator sites and regulatory documents required by the FDA, other regulatory authorities, and IRBs/ECs, as necessary across multiple studies using manual tools (such as spreadsheets) and / or a CTMS system.
- Coordinates, processes, and tracks shipments (i.e., supplies, study-related materials, etc.)
- Serves as a point of contact for study sites and contract monitors for clinical supplies, document collection and preparation for close-out.
- Responsible for the filing of documents into the TMF (paper or electronic).
- Assists with the quality review of documentation e.g., ICFs, regulatory green light packages.
- Attends study and Departmental meetings, taking meeting minutes where necessary.
- Has some understanding of the science behind Clinical Research, observes and gains exposure to clinical monitoring which may include attendance at site visits and support of investigator and other professional meetings and activities.
- Capable of handling additional task with little supervision.
- Follows ICH-GCP and FDA regulations and contributes to GCP inspection-readiness activities.
- Travel up to 5%.
THE QUALIFICATIONS
- BA/BS in equivalent field with a year or more of experience in Clinical Operations or equivalent experience without degree.
- Ability to work from SF Office 2 days per week or travel to office as policy requires.
- Proof of COVID-19 primary series vaccinations.
- Excellent interpersonal, organizational, problem-solving, and written/verbal. communication/influence skills.
- May be proficient in electronic systems e.g., eTMF or CTMS.
- 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 $106,000-$111,000 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.