Tandem Diabetes Care
San Diego, CA
Posting Title: Clinical Research Associate II
What you’ll be doing:
Work independently to implement and monitor clinical studies at participating study sites according to United States Code of Federal Regulations (CFR), Good Clinical Practices (GCP), and ICH Guidelines. Oversee and work with Outside Clinical Research Organizations to plan and execute the design and conduct of Tandem Diabetes Care, Inc.-sponsored studies. Responsible for overall study planning. Ensure that all site visits, monitoring, data collection, reports, and ancillary requirements are appropriately executed to meet company deadlines, quality expectations, and priorities. Work collaboratively with company’s R & D and Regulatory Affairs groups to compile study results, reports and/or tracking various study documentation.
Who we are:
Here at Tandem, Diabetes is all we do and we are dedicated to making the lives of people with diabetes better and better, through relentless innovation. ‘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 expectations.
We’ve have been named one of the fastest growing insulin pump companies in the U.S! Why? Designed, assembled and supported from our San Diego, CA headquarters, Tandem has created the simple-to-use t:slim X2 Insulin Pump, which is the smallest pump available, the only color touch-screen insulin pump capable of remote feature updates, and the first CGM-enabled pump approved to let users make treatment decisions without pricking their finger.
Read more about our company & culture here: and see what our customers are saying here: #tsliminthewild
What you need for this position:
PRIMARY DUTIES & RESPONSIBILITIES:
- Works cross-functionally to plan and develop clinical study logistics.
- Conducts and documents site qualification activities as well as site initiation visits.
- Conducts interim monitoring and closeout visits.
- Plans and conducts study site device training.
- Develops and reviews clinical SOPs. Maintains thorough understanding of clinical regulations and standards (including changing regulations). Creates and implements regular process improvements.
- Represents the clinical department at project team meetings as needed.
- Responsible for establishing and meeting project timelines.
- Produces study summaries, including reports, graphs and tables, as requested.
- Conducts budget negotiations with clinical sites.
- Collaborates effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders.
- Writes/reviews protocols, study reports, and other materials.
- When applicable, implements strategies for enrollment to ensure timely completion of clinical studies, in alignment with department and corporate strategic objectives.
- Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
- Performs other related duties and tasks, as required.
- Knowledge, skills & abilities:
- Demonstrated knowledge of US FDA medical device regulations related to 510(k) Class II and PMA Class III submissions; Experience with diabetes technology submissions preferred.
- Familiarity with medical device quality systems (QSR) related to regulatory activities.
- Strong attention to details with excellent organizational skills.
- Excellent technical writing, editing, and proofreading skills.
- Ability to manage multiple complex projects at same time.
- Skilled at analytical problem solving and communicating both inside and outside of the organization.
- Ability to work independently to manage all clinical study tasks and deliverables to meet clinical study timeline.
- Communicates in a professional and collaborative manner, and clarifies priorities when faced with competing deadlines.
- Skilled at promoting team cooperation and a commitment to team success.
- Offers suggestions to improve and/or streamline department procedures when issues are identified.
- Skilled with MS Office applications as well as Adobe Acrobat.
- Past experience with document management systems and electronic device submissions preferred.
- Minimum certifications/educational level:
- 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.
- Minimum experience:
- 2 years’ Regulatory Affairs experience within a FDA regulated medical device industry including:
- Administration of clinical trials required
- 510(k) submissions for infusion devices and disposables preferred.
- FDA Electronic Registration and Listing experience preferred.
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 check out our offsite gym, which boasts luxurious amenities including specialty fitness classes and state-of-the-art equipment.
Invest in your career. Tandem offers all employees access to training and development programs and courses to help keep your career and skillset updated, not outdated.
Live your life. Relax with 20 days of paid time off and celebrate 10 paid holidays in your first year. Save for your future with a company-provided 401(k) plan. Look forward to saving money on tickets to the San Diego Zoo, movies, restaurants, and so much more with our exclusive employee discount program.
Celebrate in Tandem. Join in monthly employee get-togethers, tacos for Cinco de Mayo, corned beef for St. Patrick’s Day, costume-contest for Halloween, and the annual JDRF walk.
San Diego, California, United States