Data Coordinator

Company: Amplifybio, LLC
Location: Jefferson
Posted on: March 16, 2023

Job Description:

Do you want to be part of a growing world-class organization focused on bettering our world? 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 newly established, commercially focused preclinical CRO that was created as a Battelle spin-off. Aligned with, and supported by leading life sciences-focused investors, we partner with our clients to provide preclinical CRO services from single study and through full IND enabling studies. We have a strong focus and commitment to helping accelerate the commercialization of advanced therapies such as cell and gene therapies and vaccines.

Moving forward we will combine continuous improvement and innovation to become the preferred preclinical CRO in the industry, by working in partnership with our clients, and leveraging state of the art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from concept to commercial.

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. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. 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.

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 companys 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 Youll 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. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. AmplifyBio encourages everyone including women, people of color, individuals with disabilities and those in the LGBTQIA+ community to apply for our available positions, even if they don't necessarily check every box on the job description. Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do.

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. AmplifyBio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required .

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 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 generous PTO
Life and AD&D insurance
Supplemental insurance
LiveHealth Online
Smart Shopper (helps you shop for better medical care and earn cash rewards while you save)
Generous paid parental leave
Wellness and Self-Care Programs
401(k) match
Tuition Reimbursement
EAP/work-life support system
A fun work environment where everyones voice matters
We are just getting started! More benefits on the way!
An Opportunity to Change the World!!!

Keywords: Amplifybio, LLC, Erie , Data Coordinator, Other , Jefferson, Pennsylvania