Data Coordinator
7 days ago
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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