What you’ll be doing:
Works closely with the Clinical Research Associate II, Clinical and Regulatory Affairs teams to assist with the implementation and monitoring of clinical studies at participating study sites according to United States Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and ICH Guidelines. Participates on operational calls with study teams; documents minutes as directed. Conducts site visits, coordinates team meetings and writes visit reports.
Who we are:
A San Diego-based medical device company, named a Best Place to Work through the San Diego Business Journal, that’s been making the lives of people with diabetes better and better through relentless innovation and revolutionary customer experience since 2008.
Read more about our culture here: https://www.tandemdiabetes.com/careers/life-at-tandem
What you need for this position:
Bachelor's degree in a related technical field or equivalent education and applicable work experience.
Certification (RAC) by the Regulatory Affairs Professional Society or other documented past training in medical device regulations is desirable.
2 years of administrative experience.
Works with Clinical Affairs team to plan and develop clinical study logistics.
Conducts and documents site qualification activities as well as site initiation visits.
Orders, tracks and manages shipping of investigational devices & supplies and their return, to and from clinical sites.
Conducts interim monitoring and closeout visits.
Tracks invoices and approves according to pre-specified budgets.
Plans and conducts study site device training.
Ensures compliance with Tandem SOPs. Maintains thorough understanding of clinical regulations and standards (including changing regulations). Identifies and implements regular process improvements.
Produces study summaries, including reports, graphs and tables, as requested.
Conducts literature reviews as directed
Collaborates effectively with team members and others to accomplish tasks.
When applicable, implements strategies for enrollment to ensure timely completion of clinical studies, in alignment with department and corporate strategic objectives.
Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
What’s in it for you?
We’ve got you covered.
We offer a robust benefits package to support your health and your family. From medical, dental, and vision, to flexible spending accounts for both health and dependent care – Tandem’s got you covered!
Stay well with us.
Enjoy the outdoors during your workday by biking, running, or walking on one of our nearby trails. Or, break a quick sweat at our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.
Invest in your career.
Tandem offers all regular full-time employees a company-sponsored 401(k) plan as well as the potential for stock options.
Live your life.
Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. With our exclusive employee discount program, you can look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more
Celebrate in Tandem.
Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick’s day, and the annual JDRF walk.
Make a difference, together.
“In Tandem” means together, and we strive to embody that in every aspect of our business. We believe that working in tandem, not in isolation, is the best way to continually exceed
Words we live by.
Innovate, for real.
We rely on new ideas, and people who keep their minds open to how to make them happen, to deliver products that can change people’s lives. When faced with a revolutionary concept, whether it be for a new product, or even just a new way to organize the supply room, we try to say yes (or at least maybe) before we say no.
Making things more efficient and cost effective is great! Taking shortcuts is not. People’s lives depend on us, so holding ourselves to the highest ethical standards and delivering exceptional quality in everything we do isn’t just something we value, it’s something we require.
Be casual, seriously.
Don’t let the jeans and board shorts fool you. We are very serious about our work. We also recognize that the happiest people are the most productive people, and we foster an environment to support that.
Dedicated: Devoted to a task or purpose with loyalty or integrity
Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well
Enthusiastic: Shows intense and eager enjoyment and interest
Functional Expert: Considered a thought leader on a subject
Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization
Growth Opportunities: Inspired to perform well by the chance to take on more responsibility
Goal Completion: Inspired to perform well by the completion of tasks