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Clinical Trial Associate
vor 2 Wochen
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. With over 200 “Kaianeers” spread across the globe, we need now, more than ever, specialized talent to help take our mission further.
Tasks
The Clinical Trial Associate (CTA)/In-house Clinical Research Associate (CRA) will be responsible for the general in-house management of the clinical trials of medical device studies. The key responsibilities will include:
- Support project management and administration in clinical trials of medical devices and device related feasibility studies as well as in in government funded research projects and international investigator-initiated trials
- Develop, review, and edit clinical trial related documentation (study specific documents, handbooks, guidelines, checklists)
- Develop and create Investigators Site Files
- Provide support to the infield CRAs in the conduction of site selection, study initiation, interim monitoring, and close-out visits in accordance with Good Clinical Practice (GCP) regulations and standard operating procedures (SOPs)
- Manage clinical trial documentation including the Trial Master File (TMF), perform periodic TMF reviews and follow up on outstanding items until resolution
- Set-up and maintain tools for tracking documentation, payments, and all clinical trial related activities
- Disseminate clinical trial related information including project tracking updates to the Clinical Project Manager (CPM), clinical trial teams and other departments
- Act as the central contact for the clinical trial team and trial sites for designated project communications, correspondence, and associated documentation
- Prepare and coordinate specified clinical trial meetings (Investigator Meetings, study team meetings) and create and distribute meeting agendas and minutes
- Support clinical trial teams in ethics and regulatory submissions: Collect essential documents and review essential documents for proper content, liaise with the CRAs and clinical trial sites to resolve outstanding issues
- Prepare devices for clinical trial participants and ensure proper supply at clinical trial sites
- Support vendor management
- Participate in feasibility and/or site identification activities
**Requirements**:
**Skills required**:
- BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience
- Minimum of 1 year of experience in Clinical Research, e.g., as a CTA, CRA or start-up specialist
- Good knowledge of ICH-GCP, basic monitoring procedures and basic understanding of the overall clinical trial process
- Ability to effectively analyze project specific data/systems to ensure accuracy and efficiency
- Prior experience in general remote site management activities and clinical trial administrative tasks plus understanding of the national laws and regulations governing medical device studies
- Fluid oral and written communication in German (at least C2 level) and English
- Excellent communication and interpersonal skills
- Flexibility and ability to work independently to coordinate with the CPM all necessary activities required to set up, conduct and close-out a study
- Attention to detail and ability to prioritize tasks effectively
- Curiosity to work in the new and rapidly evolving field of digital therapeutics
- Based in Munich or within one hour of travel around Munich, ready and willing to spend at least two days per week in the office
**Benefits**:
- A competitive salary
- Occupational pension plan opt-in
- Gym membership subsidy
- Mobile Plan
- Child Care subsidy opt-in
- Transportation Allowance up to 60€ per month
- Meal allowance up to 100€ per month
- A laptop of your choice (Mac or PC) up to 2,000€
- 600€ budget for peripherals
- An annual budget of 1,200€ dedicated to your personal development
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