Data Coordinator

3 weeks ago

West Jefferson, United States Amplifybio, LLC Full time
Job DescriptionJob Description

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join 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.

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.

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. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies.

AmplifyBio is currently seeking to hire a Data Coordinator to join our growing team

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.

AmplifyBio is rapidly expanding its service offerings related to the discovery, translation, and development of advanced therapies such as gene and cell therapies. As part of the team, the right candidate will help support the company’s growing portfolio of service offerings and commercial capabilities. This is a unique opportunity to be part of an emerging startup bringing innovative technology to advanced therapies.

What You’ll Do Here:

  • 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.
  • Perform other duties as assigned.

We Would Love to Hear from You If:

  • 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.
  • Applicants for this position must be a U.S. person, as defined by U.S. export control laws. A U.S. person may include individuals that are U.S. citizens, U.S. nationals, lawfully admitted permanent residents, or refugees and asylees.
  • Must be willing to be immunized with licensed and FDA approved vaccines and medications recommended for persons at risk to occupational exposure of biological agents.
  • Must be willing to participate in periodic drug screening.
  • Must be willing to work evening, weekend, and holiday hours, as necessary.
  • Newly hired employees are subject to a 90-day introductory period, during which their performance is evaluated by supervision.
  • 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).

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

Why You Will Love Working Here:

We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), to financial planning and legal assistance, we make sure to take care of our own.

  • 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

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.

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