Data Coordinator

2 weeks ago

Reston, Virginia, United States AmplifyBio Full time
About AmplifyBio

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.

About ASET West Jefferson, OH

AmplifyBio's safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes.

Job Summary

The Data Coordinator is responsible for maintaining study files, reviewing data in real time, and ensuring that SOP, Protocol, and GLP requirements are met. This position will join a staff of highly trained scientist and technicians, and state of the art facilities to support our clients' toxicology, safety pharmacology, and inhalation research programs.

Key Responsibilities
  • Create and securely maintain study files in accordance with SOPs, Protocol, GLPs and client specifications.
  • Perform real-time quality control and/or technical review of electronic and/or paper data.
  • Capture quality metrics and escalate trends to management for continuous improvement.
  • Communicate and collaborate across team and functional groups to address and clarify data capture discrepancies.
  • Prepare deviations according to SOP.
  • Prepare and submit study files for QAU audit.
  • Assist with responses to QAU audits.
  • Assist with report preparation and review as needed.
  • Prepare study files for archiving per SOP, GLP and client specifications.
  • Mentor and train junior staff in Data Coordinator duties.
Requirements
  • Bachelor's Degree, equivalent combination of education, training, and experience may be substituted for degree.
  • Knowledge of GLP regulations and guidelines; basic quality review techniques.
  • Strong interpersonal skills.
  • Excellent problem-solving skills.
  • Effective organization, communication, and team orientation skills.
  • Ability to initiate assigned tasks, to work independently, and manage time.
  • Ability to manage multiple projects.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • Must be willing to work in a biosafety level 2 (BSL2) and/or 3 (BSL3) environment and able to wear appropriate respiratory protection.
  • Experience using the Provantis Data capture system to input and review data.
  • Experience reviewing in-vivo and in-vitro data including, but not limited to, inhalation, pathology, chemistry, PCR, and ELISA.
  • Experience with Microsoft software (WORD, EXCEL, PowerPoint).
What We Offer
  • Health, Dental, and Vision insurance that starts on your first day at AmplifyBio.
  • Competitive Compensation Package.
  • We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy.
  • Generous paid parental leave.
  • Wellness and Self-Care Programs.
  • 401(k) match.
  • Tuition Reimbursement.
  • EAP/work-life support system.
  • A fun work environment where everyone's voice matters.
  • An Opportunity to Change the World.

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