Clinical Research Associate

3 weeks ago

Reston, Virginia, United States 89bio Full time
Job Title: Clinical Trial Associate

89bio is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for liver and cardio-metabolic diseases. Our team is passionate about making a difference in the lives of patients, and we're seeking a highly motivated Clinical Trial Associate to join our team.

Job Summary:

The Clinical Trial Associate will play a critical role in the planning and management of clinical trials, ensuring compliance with company policies and applicable regulations. This position requires strong organizational and communication skills, as well as the ability to work effectively in a fast-paced environment.

Key Responsibilities:
  • Prepare and maintain clinical study files, regulatory binders, and operations manuals for clinical sites.
  • Collect, process, and track investigator sites and regulatory documents required by the FDA and other regulatory authorities.
  • Coordinate and process shipments of clinical supplies and study-related materials.
  • 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, including ICFs and regulatory green light packages.
  • Attend study and departmental meetings, taking meeting minutes as necessary.
  • Develop a strong understanding of the science behind clinical research and observe clinical monitoring activities, including site visits and investigator meetings.
  • Capable of handling additional tasks with minimal supervision.
  • Ensure compliance with ICH-GCP and FDA regulations and contribute to GCP inspection-readiness activities.
Requirements:
  • BA/BS in a relevant field with a year or more of experience in clinical operations or equivalent experience without a degree.
  • Ability to work from our San Francisco office 2 days per week or travel to the office as required.
  • 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.
What We Offer:
  • Competitive health insurance coverage.
  • Generous PTO allowance.
  • 401k match.
  • Employee Stock Purchase Plan (ESPP).
  • Commuter Benefits.
  • Women's forum/mentoring.
  • Office located in the heart of San Francisco, near shops and restaurants.
  • Fun opportunities to engage with coworkers in-person and remotely.

89bio is an equal opportunity employer and welcomes applications from diverse candidates. Proof of COVID-19 vaccination is a condition of employment. Notice to recruiters: 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.

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