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 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.
- Assist the clinical project team to initiate, conduct, and complete Phase 1 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.
- Develop and maintain nonclinical supply materials such as study support documents and reference manuals (study reference and pharmacy manuals, initial site regulatory binder).
- Order nonclinical supply materials, and generate and maintain tracking of these materials.
- Request and track investigator payments, as needed. Work with Clinical Operations and Finance to resolve payment issues.
- Assist in creation of studies within the system per SOPs, track study-specific data, and generate reports.
- Assist in the distribution of key clinical trial documents (ie, investigator brochures, protocols, informed consents, regulatory submissions).
- Receive and review regulatory documents from clinical sites.
- Maintain effective tracking systems and communication with internal and external customers to ensure updates of appropriate regulatory documents (ie, 1572s, financial disclosures).
- Coordinate documentation for clinical study supply releases with investigator sites and ensure that Regulatory is provided with 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.
- Maintain files of clinical trial documents for ongoing projects and assist in the archival of CRO study files and legacy 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.
- Assemble documents and supplies as needed to support monitoring visits. Travel, as needed, to train clinic staff on study protocol and product use.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, open communications
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- BS degree in life science or nursing
- 0 - 4 years’ experience as a clinical trial assistant or study coordinator. Or, an associate degree or equivalent with 4 years of clinical trial experience, specifically working with regulatory documents or tracking documents or as a clinical trial assistant.
- 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.
- 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 and MS Office
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