Data Coordinator

7 days ago


Jefferson, Ohio, United States Amplifybio, LLC Full time

About the Role:

AmplifyBio, LLC is seeking a highly skilled Data Coordinator to join our team. As a Data Coordinator, you will be responsible for maintaining study files, reviewing data in real-time, and ensuring that SOP, Protocol, and GLP requirements are met.

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.
  • Must be willing to work evening, weekend, and holiday hours, as necessary.
  • 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).

About AmplifyBio, LLC:

AmplifyBio, LLC 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.

Why Work at AmplifyBio, LLC:

  • 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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