Clinical Research Coordinator

2 days ago

Reston, Virginia, United States 89bio Full time

About 89bio

89bio is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for the treatment of liver and cardio-metabolic diseases. Our lead product candidate, pegozafermin, is a glycoPEGylated analog of FGF21, being developed for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG).


Job Summary

The Clinical Trial Associate will play a crucial role in planning and managing the conduct of clinical trials in accordance with company policies and procedures, as well as applicable regulations. This position may involve some travel when conditions allow.


Key Responsibilities

  • Prepare and maintain clinical study files, regulatory binders, and operations manuals for clinical sites, including investigator 1572s, informed consent forms, protocols, and investigator brochures.
  • Collect, process, and track investigator sites and regulatory documents required by the FDA, other regulatory authorities, and IRBs/ECs, as necessary across multiple studies using manual tools and/or a CTMS system.
  • Coordinate, process, and track shipments of supplies, study-related materials, and other essential items.
  • Serve as a point of contact for study sites and contract monitors for clinical supplies, document collection, and preparation for close-out.
  • Responsible for filing documents into the TMF (paper or electronic).
  • Assist with the quality review of documentation, such as ICFs and regulatory green light packages.
  • Attend study and departmental meetings, taking meeting minutes as necessary.
  • Gain exposure to clinical monitoring, including attendance at site visits and support of investigator and other professional meetings and activities.
  • Capable of handling additional tasks with minimal supervision.
  • Follow ICH-GCP and FDA regulations and contribute to GCP inspection-readiness activities.
  • Travel up to 5%.


Requirements

  • BA/BS in an equivalent field with a year or more of experience in Clinical Operations or equivalent experience without a degree.
  • Ability to work from the SF Office 2 days per week or travel to the office as policy requires.
  • Proof of COVID-19 primary series vaccinations.
  • Excellent interpersonal, organizational, problem-solving, and written/verbal communication/influence skills.
  • Proficiency in electronic systems, such as eTMF or CTMS.
  • Proficiency in MS Word, Excel, and Project.
  • Experience with electronic data capture, reviewing, and interpreting data is desired.


Benefits

89bio offers a competitive benefits package, including health insurance coverage, a generous PTO allowance, 401k match, Employee Stock Purchase Plan (ESPP), commuter benefits, and a women's forum/mentoring program. Our office is located in the heart of San Francisco, near plenty of shops and restaurants, and we offer fun opportunities to engage with coworkers in-person and remotely.


Equal Employment Opportunity

89bio is an equal opportunity employer and welcomes applications from all qualified candidates. We are committed to diversity, equity, and inclusion in the workplace and strive to create a welcoming environment for all employees. Proof of Covid vaccination is a condition of employment.

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