Company details

Kaia is a mission-focused health technology company.

Our story began in 2016, when our founders Konstantin Mehl and Manuel Thurner, set out on a mission to bring affordable and accessible relief to millions of people with chronic conditions. No strangers to chronic pain themselves, they decided to innovate ways to remove the obstacles many people experience in getting the leading-edge care they need in order to live their best lives.

How do Kaia apps work? Kaia uses a dynamic AI-powered algorithm. Our programs are based on multimodal rehabilitation, a holistic approach to managing chronic conditions. Our users have easy access via smartphone and tablet to our programs for back/hip/knee pain and COPD using this evidence-based approach.

Five years into our story, we are a leader in digital therapeutics, with 500,000+ users worldwide. Having raised $125 million from investors such as Optum Ventures, idInvest, and Balderton Capital. We are poised to create a global footprint in digital self-care; Kaia is patient empowerment made easy.

The regulatory landscape is quickly adapting to the digital ecosystem. Therefore, our mission and strategy bring new opportunities for exceptional talent to join our journey.

Job details

Kaia is currently conducting a randomized, controlled, multicentered and multinational clinical study to evaluate the effects of a digital therapeutic application on the self-management of COPD patients.

Kaia is looking for an experienced Freelance Clinical Research Associate available at 32 hours per week for a fixed term contract of up to 12 months, with the option of reducing hours to 20 hours per week after three months. The successful applicant will be the primary point of contact between site staff and Kaia and will be responsible for performing site initiation visits, interim monitoring visits and close-out visits in compliance with global and local regulations, ICH-GCP, medical device regulations (Medical Device Regulation EU 2017/745, ISO 14155), protocol requirements and sponsor procedures.

Responsibilities:

• Monitor the progress of the trial on-site and remotely in accordance with applicable guidelines.
• Motivate and build strong relations with site personnel to assist Kaia in being the sites’ preferred clinical research partner.
• Train and guide site staff in safety information handling, systems usage, protocol, and trial procedures to minimize protocol deviations.
• Support study sites with subject recruitment, query resolution and perform ongoing data cleaning.
• Help sites with technological issues with the study intervention in collaboration with Kaia’s IT team.
• Proactively use EDC and other data source systems for preparation and conduct of site visits as well as source data review and source verification in collaboration with data management/project team.
• Verify subject eligibility.
• Maintain and manage clinical trial documentation in the investigator site file and trial master file.
• Identify potential risks and proactively take action to prevent or mitigate.
• Escalate issues observed at sites to the project manager in a timely manner.
• Provide support in the completion of ethics and regulatory submissions.
• Support the project manager with administrative tasks as applicable.
• Maintain knowledge of and act in compliance with global and local regulations, ICH-GCP, medical device regulations (Medical Device Regulation EU 2017/745, ISO 14155), protocol requirements and sponsor procedures.

Requirements:

• BA/BS degree in science, health care or nursing degree or equivalent combined education and experience.
• Excellent knowledge of applicable global and local regulations, ICH-GCP and medical device regulations (Medical Device Regulation EU 2017/745, ISO 14155).
• At least two years of current independent monitoring experience.
• Experience with monitoring of medical device trials preferred.
• Flexibility and ability to work independently and proactively to coordinate all necessary activities required to set-up, initiate, and monitor a study.
• Availability of at least 32 hours/week to work for Kaia on a fixed term contract of up to 12 months, with the option of reducing hours to 20 hours per week after three months.
• Fluid oral and written communication skills in German and English.
• Excellent communication and interpersonal skills.
• Effective time management and organizational skills as well as a keen attention to detail.
• Advanced computer skills including but not limited to use of MS office, use of various clinical IT applications on computer, tablet and mobile devices and ability to adapt to new IT applications on various devices.

This is an excellent opportunity for any individual who is eager to work with a young and dynamic sponsor and who is looking to influence the future of digital health in a team of industry experts and digital shapers.