Study Coordinator
Company: Amplifybio, LLC
Location: West Jefferson
Posted on: March 20, 2023
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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. 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 AmplifyBioCompetitive
Compensation Package We take work-life balance seriously and we
back it up with generous PTOLife and AD&D insurance
Supplemental insuranceLiveHealth OnlineSmart Shopper (helps you
shop for better medical care and earn cash rewards while you save)4
weeks paid Parental LeaveWellness Program401(k) matchTuition
Reimbursement EAP/work-life support systemA fun work environment
where everyone's voice mattersWe are just getting started! More
benefits on the way!An Opportunity to Change the World!!!
PI208427983
Keywords: Amplifybio, LLC, Columbus , Study Coordinator, Other , West Jefferson, Ohio
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