About Happify Health
Happify Health is a global software-enabled healthcare platform. We design and deploy software to help improve mental health, physical health and well-being. We are creating a future where better health outcomes can be powered by technology—leading to more personalized care that can improve the everyday lives of more people. The Happify Health platform offers a full spectrum of science-backed Digital Therapy and Care Journey solutions for customers and individual end-users; including Wellness, AI-based Coaching, Community, as well as Combination and Prescription Digital Therapeutics.
Our patient solutions are disseminated through unified products and services we deploy for the healthcare ecosystem; including enterprises, health plans, health systems, pharma and medical device manufacturers. Our global platform is available in 10 languages, supports more than 10 chronic conditions, and covers more than 20 million lives. For more information, visit www.happifyhealth.com.
About the Role
As the Clinical Operations team continues to grow at Happify, we are looking for self-starters with a strong desire to learn and develop new skills in a fast-paced environment. The Clinical Trial Coordinator is a part of the clinical operations team, responsible for supporting study implementation of decentralized digital therapeutic clinical studies and ensuring each study is in compliance with the protocol, Good Clinical Practices, regulatory requirements (ISO 14155, FDA 812), and Happify standard operating procedures. Working with the Clinical Operations Manager and Clinical Trial Coordinators, you will own administrative day-to-day project activities that support one or more clinical trials.
- Write, submit, and revise IRB applications
- Support the development and implementation of study protocol(s) and other study documents (Investigator’s Brochures, Informed consent Documents, Safety and Monitoring Plans, Study Training Materials etc.) in accordance with Good Clinical Practices (GCPs) and current Standard Operating Procedures.
- Create and maintain entries in clinicaltrials.gov
- Regularly interact with high-level internal and external stakeholders to coordinate the accomplishment of business needs
- Plan, coordinate, and arrange study communications and critical meetings on and off-site with both internal and external attendees, as well as drafting meeting agendas and detailed meeting minutes
- Set up, update, maintain and close Trial Master Files. Assures currency and accuracy of required clinical trials documents (i.e. CVs Medical Licenses, Laboratory documentation, Financial Disclosures, Investigator Agreements, etc.)
- Bachelor’s degree is required with a strong interest in using technology for behavior change.
- 1 - 2 years FDA medical device research experience is required.
- Experience with preparation and submission of protocols and associated documents for Research/Human Subjects Committee (IRB) approval.
- Familiarity with the process of drafting study documents (protocols, ICFs, study plans).
- Ability to manage multiple tasks concurrently and to prioritize work appropriately.
- Excellent organizational and communication skills, strong attention to detail, and ability to pick up new research-related skills quickly, including interacting with the web-based Happify admin tools.
- Strong desire to learn and grow with the company.
- Ability to thrive in a fast-paced, technical, and mission-focused environment.
Happify values candidates with different backgrounds, experiences, and perspectives. We do not discriminate based upon ethnicity, age, gender identity and expression, sexual orientation, religion, national origin, socioeconomic status, disability, or veteran status. We're committed to building a company that is an inclusive environment for all.
There have been cases of scams targeting candidates by individuals pretending to work at Happify. We will never ask you to share financial information to participate in our recruiting process. If you suspect that you've been contacted by a scammer, please consider filing a report with law enforcement. If you'd like to verify an email you received from Happify, please write us at firstname.lastname@example.org.