Clinical Research Associate (Midwest Remote)
Clinical Research Associate (Midwest Remote)
Who we are
AVITA Medical is a Class III medical device company looking for a full-time Clinical Research Associate to help sustain our expanding line of indications. AVITA is headquartered in Valencia, CA, and manufactures in Ventura, CA. Come join our team and be part of our growth!
WHAT we are looking for:
The Clinical Trial Associate serves as a key resource for the Clinical Research Department in the coordination of activities (primarily administrative) associated with AVITA’s clinical trials.
Duties/Responsibilities
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- Maintain and/or accelerate timelines for achieving clinical research milestones
- File, track, and maintain paper and electronic Trial Master File (eTMF) assisting the clinical research team to ensure documents meet FDA/ICH/GCP requirements
- Coordinate execution of Non-Disclosure (NDAs), MSAs, CTAs, and consulting agreements
- Participate in the design of study manuals, CRFs, etc.
- Assist clinical teams with study supplies management
- Prepare and distribute Investigator Site Files (ISFs) / Regulatory Binders
- Create purchase requisitions and track vendor and clinical trial expenses and reconcile against budget, contract, and PO
- Track and submit monthly accrual information to the finance department
- Conduct study tracking activities (sites status, enrollment status, reconciliation activities, filing & archiving)
- Coordination of logistics for departmental and clinical research meetings/events: scheduling meetings, meeting agendas, meeting minutes, meeting materials (creating PowerPoint Presentations), and coordination of travel arrangements, off-site meeting rooms, etc.)
- Perform other duties as requested
Skills / Experience
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- Ability to work independently as well as collaboratively in a dynamic, fast-paced, timeline-based environment
- At least one year of experience working in clinical research and/or knowledge of Good Clinical Practice (GCP) is preferred
- Commitment to excellence and high standards
- Flexibility and a proactive orientation
- Excellent organizational skills along with strong attention to detail
- Excellent verbal and written communication, strong organizational and interpersonal skills
- Proficiency with Word, Excel, PowerPoint, Adobe
Education / Experience:
Bachelor’s Degree or equivalent clinical, healthcare, or laboratory-related work experience is strongly preferred.
Travel Expectations
The ability to travel and support clinical research off-site meetings and events may be required (approximately 65%).
Information Security Compliance
AVITA Medical recognizes the role of information security in ensuring that users have access to the information they require to carry out their work in a secure manner.
AVITA Medical is committed to protecting the security of its information and information systems. As such, each role within AVITA Medical must demonstrate the same commitment to information security.
The teams that work at AVITA Medical
make all the difference — Join us!