Clinical Research Associate
Employment Type: Full-Time
89bio is a clinical-stage biopharmaceutical company focused on rapidly advancing our lead product candidate, BIO89-100, through clinical development for the treatment of non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). BIO89-100 is a specifically engineered glycoPEGylated analog of the metabolic hormone, fibroblast growth factor 21 (FGF21).
In September of 2020, the Company announced positive topline results from its Phase 1b/2a trial with BIO89-100 in patients with nonalcoholic steatohepatitis (NASH) Click HERE for press release. The Company believes these successful proof of concept results validate their view they have a very promising and differentiated FGF21 program.
The Company has also recently initiated its Phase 2 proof of concept study in SHTG. SHTG is characterized by triglyceride levels ≥500 mg/dL, and is associated with an increased risk of NAFLD, NASH, and cardiovascular diseases, as well as acute pancreatitis. It is estimated that there are 2.5 million to 4 million patients in the US with triglyceride levels ≥500 mg/dL. BIO89-100 has the potential to be a differentiated treatment that can potentially lower triglyceride levels while also offering improvements in liver fat and other metabolic comorbidities.
89bio is headquartered in San Francisco with operations in Herzliya, Israel. The Company closed it's upsized initial public raising a gross of $97.6 million in November of 2019 and raised over $160 million in July and September of 2020.
Reporting to the Senior Director of Clinical Operations, the Clinical Research Associate (CRA) will participate in planning and assisting in overseeing the conduct of clinical trials in accordance with Company policies and procedures and applicable regulations. The role is based in the San Francisco office and may include some travel when conditions allow.
* Manage 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
* Oversee 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, and vendors (e.g., CROs, central Labs)
* Manage the overall activities of CROs, central labs, core labs, drug distribution center, and regional monitors
* Coordinate the development of Clinical Trial Agreements with appropriate Company business associate and develop study budgets
* Review and negotiate clinical site budgets
* Provide 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, develop /direct clinical study monitoring priorities and assist in writing monitoring plans; evaluate these activities when conducted by CRO
* Identify clinical supplies required for the conduct of specific clinical trials and manage supplies for Company-based studies
* Provide training and guidance on addressing issues of protocol compliance, safety, data and administrative issues with investigational sites and/or regional/CRO monitors as applicable
* Assist the Medical Monitor with identifying trends in safety observed in the study over time
* Analyze/report safety issues, patient care issues, and study design and/or study conduct issues
* Assist with the preparation of safety, interim and final study reports, and resolution of data discrepancies
* Travel up to 25%
REQUIRED EDUCATION, SKILLS & EXPERIENCE
* BA/BS in equivalent field
* 4 years of experience in Clinical Operations (broad knowledge of FDA regulations, GCP, clinical trial design and documentation, conducting & monitoring of clinical trials, and some knowledge of auditing procedures; development & administration of budgets, schedules and performance requirements)
* Experience managing international multi-site studies
* Prior experience managing CRO's
* History of successfully meeting group & company objectives; providing technical advice and assisting with problem resolution; working well under pressure/tight deadlines
* Excellent interpersonal, organizational, problem-solving, and written/verbal communication/influence skills; confidence and experience of effectively working/leading/influencing a wide variety of medical, research, and administrative personnel within and outside the company
* Proficiency in MS Word/Excel/Project
* Experience with electronic data capture/reviewing/interpreting data desired
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 on the basis of disability.
Reference # 14462 Posted on 25 Oct 2020 Closes on 23 Apr 2021 07:14 Property name 89bio Inc Location(s) San Francisco, CA Department Career level Hours/Status More details (document)