Clinical Operations Specialist

3 days ago


Reston, Virginia, United States 89bio Full time
About the Role

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 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.

Key Responsibilities
  • Document Management: Prepares and maintains documents and files such as clinical study files, regulatory binders, and operations manuals for clinical sites.
  • Site Management: Collects, processes and tracks investigator sites and regulatory documents required by the FDA, other regulatory authorities, and IRBs/ECs, as necessary across multiple studies.
  • Supply Chain Management: Coordinates, processes, and tracks shipments of clinical supplies and study-related materials.
  • Point of Contact: Serves as a point of contact for study sites and contract monitors for clinical supplies, document collection and preparation for close-out.
  • Document Filing: Responsible for the filing of documents into the TMF (paper or electronic).
  • Quality Review: Assists with the quality review of documentation e.g., ICFs, regulatory green light packages.
  • Meeting Support: Attends study and Departmental meetings, taking meeting minutes where necessary.
  • Scientific Understanding: 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.
  • Additional Tasks: Capable of handling additional task with little supervision.
  • Regulatory Compliance: Follows ICH-GCP and FDA regulations and contributes to GCP inspection-readiness activities.
  • Travel: Travel up to 5%.
Requirements
  • Education: BA/BS in equivalent field with a year or more of experience in Clinical Operations or equivalent experience without degree.
  • Work Arrangement: Ability to work from SF Office 2 days per week or travel to office as policy requires.
  • COVID-19 Vaccination: Proof of COVID-19 primary series vaccinations.
  • Skills: Excellent interpersonal, organizational, problem-solving, and written/verbal communication/influence skills.
  • Technical Skills: May be proficient in electronic systems e.g., eTMF or CTMS.
  • Software Proficiency: Proficiency in MS Word/Excel/Project.
  • Desirable Experience: Experience with electronic data capture/reviewing/interpreting data desired.
About 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).


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