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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 looking to hire a Study Coordinator to join our growing Study Management team!!!

The Study Coordinator is responsible for assisting the Study Director with all aspects of the study, including overseeing pre-study, in-life, and reporting phases of a study. 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 AmplifyBio’s Study Management 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:

• Add study information to Electronic Database and keep up to date.
• Assist with protocol/amendment development, timeline creation, and IACUC submission.
• Study start preparation, including animal requests, request for equipment, generating study distribution list, Provantis protocol set up and table generation, study calendar review, and scheduling pre-study meetings.
• Prepare study specific in-life forms, labels, and memos.
• Attend critical in-life events as needed.
• Prepare deviations according to SOP.
• Notify Master scheduler of study phase changes.
• Assist with responses to QAU audits.
• Monitor report timelines, assist with report generation and perform report QC.
• Assist in the preparation of study files for archiving per SOP, GLP and client specifications.
• Mentor and train junior staff in Study Coordinator duties.

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.

Desired Skills:

• Experience using the Provantis Data capture system to set up protocols, generate tables, 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. Reasonable accommodations will be considered.

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)
• Wellness Program
• 401(k) match
• Tuition Reimbursement
• EAP/work-life support system
• A fun work environment where everyone’s voice matters
• We are just getting started! More benefits on the way!
• An Opportunity to Change the World!

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