Senior Research Associate
Company: Sarepta Therapeutics
Location: Dublin
Posted on: August 7, 2022
|
|
Job Description:
Sarepta Therapeutics is seeking a motivated Senior Research
Associate with experience working in a GCP/GLP environment for a
clinical and/or research operations support role. The team member
will collaborate with the internal and external associates in
planning, execution and management of sample logistics, strategy,
and operations. This position will support process development,
training and oversight related to the transfer of samples from
collaborators, vendors and CROs to Sarepta and third-party
facilities. Further, they will oversee and coordinate training of
less-experienced staff on GCP/COC and laboratory processing related
to sample handling and management tasks. Working closely with the
clinical operations and research teams, the team member will
support the training of domestic and international biopsy surgical
and laboratory sites, distribution of training materials related to
sample management and maintain training documentation records.
Additionally, this person will maintain the site and sample
tracking database system (Zudy, etc) and assist with budget and
invoice tracking and organization of SOWs and POs.
Primary Responsibilities include:
Support training of clinical sites to allow enrollment of patients
in Sarepta Muscular Dystrophy studies
Laboratory site initiations and training coordination
Facilitate sample logistics and manage clinical sample chain of
custody
Manage and oversee sample management process development, SOW's and
PO's
Sample and database management
Assist with coordination and tracking of clinical trial
supplies
QC activities of clinical trial sample documentation
Direct contact for the CTM's related to clinical trial
activities
Ensure compliance with GCP/ GLP guidelines
Coordinate training for biopsy surgical sites including revision,
distribution and tracking of SOPs and manuals
Support virtual and onsite training meetings, track and assemble
training documentation and certifications
Collaborate with Clinical Operations, Data Management,
Biostatistics and vendors for data transfer and analysis needs
Support communications and build relationships with key
stakeholders including CROs, vendors and external collaborators
Assist laboratory teams with writing and reviewing SOPs, reports,
publications
Assist with budget and invoice tracking for activities with
external vendors and CROs
Support setting up and tracking of new contracts and change orders
to existing contracts
Assist with tracking of departmental metrics
Support tracking of assay development and validation activities
This position will cover both non-clinical and clinical
interactions with internal and external collaborations
Desired Education and Skills Requirements:
B.S. degree in Biology, Biochemistry, or related field and 5+ years
hands-on clinical sample management or research operations
experience in biotech or healthcare setting working in a GCP/GLP
environment.
Ability to exercise discretion and judgment in handling
confidential information and will follow FDA regulations, ICH
guidelines and GCP in all tasks
Strong organizational skills are required, as well as the ability
to balance changing priorities
Demonstrated technical proficiency and quality of sample handling
with strict adherence to laboratory SOPs
Track record of solid teamwork and collaboration
Desire to work in a dynamic, fast-paced team environment and to
make a difference in the lives of people through our innovative
medicines
Demonstrates the ability to communicate clearly across multiple
parties, problem solve complex issues, and develop new training
material and/or procedures
Excellent technical writing and communication skills; able to
articulate complex technical concepts to diverse functional groups
and external stakeholders.
This position will require on-site activities
This position requires work on site at one of Sarepta's facilities
in the United States. Candidates should be aware that Sarepta
currently maintains a policy requiring all US-based employees to be
fully vaccinated against COVID-19 in order to work on site. Newly
hired employees must be vaccinated prior to their employment start
date. Sarepta is an equal opportunity employer and will provide a
reasonable accommodation to those unable to be vaccinated where it
is not an undue hardship to the company to do so as provided under
federal, state, and local law.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit
package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action
employer and participates in e-Verify.
PI185394352
Keywords: Sarepta Therapeutics, Columbus , Senior Research Associate, Other , Dublin, Ohio
Click
here to apply!
|