Clinical Trial Associate
JUUL Labs’ mission is to impact the lives of the world’s one billion adult smokers by eliminating combustible cigarettes. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.
We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career at one of the fastest growing companies is compelling, read on for more details.
ROLE AND RESPONSIBILITIES:
The Clinical Trial Associate (CTA) is responsible for performing multiple tasks that support clinical trials, with duties that include assisting clinical operations staff with activities related to clinical trials, creating and maintaining documents and tracking systems, maintaining accurate files and filing systems, etc. This role is responsible for the development, planning, documentation, and delivery of clinical trial training materials according to industry guidance, best practices, and any compliance mandates required by the organization.
- Assist the clinical operations team to initiate, conduct, and complete Phase 1 – 4 clinical trial activities. Provide accurate and up-to-date site information to Operations team and cross-functional collaborators as needed.
- Develop and implement accurate tracking systems, forms, and other relevant documents to support clinical trial studies
- Assist the clinical operations team with vendor management, including tracking all study invoices and payments
- Prepare and/or review study-related or essential study start-up documents as they relate to the supported clinical trials (e.g., clinical protocols, informed consent forms, Investigator Brochures, pharmacy manual, and relevant study plans and charters)
- Prepare correspondence, spreadsheets and presentations utilizing Microsoft Office Suite, for project specific studies. Develop and maintain project specific plans, documents and tools for the Clinical Team
- Periodic review and QC of the TMF to support inspection readiness and archiving of completed studies
- Maintain files of clinical trial documents for ongoing projects and assist in the archival of CRO study files and documentation
- Coordinate logistics for study meetings, medical expert meetings, investigator meetings, kick-off meetings, etc. Prepare draft minutes from the various meetings for review and finalization by the study team
- Develop/Maintain department training materials and trackers as required
- Provide training and support to clinical operations onboarding staff
- Work with QC to develop training modules in JUUL’s learning management system
- Assist in development of study specific training and product training
- Coordinate clinical study documentation (e.g., best practices and lessons learned, frequently asked questions, etc.) in collaboration with the study team
- Coordinate documentation for clinical study supply releases with investigator sites and maintain appropriate documentation of approved investigator sites that will allow centers to be opened, eg, IRB/EC approvals.
- Submit and track essential documents to the trial master file (TMF) on an ongoing basis and perform periodic review of TMF and clinical development documents throughout the project life for completeness and accuracy.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, open communication
SKILLS AND EXPERIENCE REQUIRED:
- BS degree in life science or nursing
- 3+ years’ experience as a clinical trial assistant or clinical project associate working in sponsors and/or CROs
- Experience supporting clinical trial managers or clinical project managers with multiple multi-site clinical trials
- Knowledge of ICH GCPs and other applicable regulatory requirements
- Excellent interpersonal and organizational skills, as well as the ability to effectively prioritize tasks.
- Strong problem-solving skills, and ability to work independently as well as work collaboratively in a team-oriented environment.
- Able to make effective use of the resources at hand and can easily adapt to change
- Effective oral and written communication skills. Must be able to communicate effectively with members of other departments and with study-site personnel (physicians, study coordinators, nurses, etc) as needed.
- Proficient with computer applications: Google Suite, MS Office, Smartsheet
JUUL LABS PERKS & BENEFITS:
- A place to grow your career. We’ll help you set big goals - and exceed them
- People. Work with talented, committed and supportive teammates
- Equity and performance bonuses. Every employee is a stakeholder in our success
- Boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits
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