Clinical Research Associate, US
Posted on Saturday, September 16, 2023
As an innovative research institute, Alcedis provides clinical research services with a modern information technology architecture. Our flat hierarchies and a decision-friendly culture creates a flexible and dynamic environment.
We are currently looking for a remote based Clinical Research Associate / Clinical Monitor / Site Manager to support our Clinical Operations department in monitoring and ensuring quality features on site.
In this role you will independently supervise a number of sites (United States and/or Canada) and will be in regular contact with the responsible project manager at Alcedis, Germany.
- Support in the organization of the study on site and supervision of the investigators
- Prepare, execute and follow-up on initiation, monitoring and completion visits (on and off-site)
- Monitor the study status on sites as well as any related documentation, according to predefined guidelines
- Validate the study data collected by investigators (source data verification)
- Prepare monitoring reports
- Review study sites for compliance with applicable guidelines and laws
- Coordinate with the data manager and the project manager
- Create queries and monitor the query process
- Train investigators and study coordinators on EDC software
- Conduct feasibility testing for new projects with study sites
- Support and coordinate sites (documentation, escalation of issues, etc.)
- Prepare documents for submission to authorities and ethics committees
- Focus mainly on non-interventional studies
From day one in this role we’ll expect you to have
- A degree in the field of natural sciences or life sciences, a comparable qualification or experience as a study nurse
- Experience with submission to IRB / ethics committee and in data privacy and protection
- The ability work independently and with foresight in planning and implementation
- Excellent communication and organizational skills
- The ability to work well in a team
- Excellent English language skills (spoken and written)
- The willingness and flexibility to travel for site visits across the US and Canada
It’s great, but not required, if you
- Have experience in conducting GCP-compliant clinical studies
- Enjoy working with electronic data and databases
- Have good knowledge of office applications
What we can offer you
- 15 paid vacation days
- Health, dental and vision insurance for you and your dependents
- Employee life insurance
- A pleasant atmosphere in a future-oriented and secure working environment
- Exciting and challenging projects
- Varied responsibility with the freedom to work independently and on your own initiative
- Flat hierarchies combined with an open corporate culture
- A successful, committed and open team
- Flexible working hours
Come join us!
We believe magic happens when you bring together diverse ideas, experiences, and styles. We want to create a world where people live longer, fuller lives, and to do that well we need a team that represents all of the people and communities who use our solutions. We aspire to create an environment where everyone has the opportunity to do their best work. We are always looking for ways to improve so if you have any suggestions, please get in touch.
Dear recruitment agency friends: Huma attracts an amazing number of direct candidates and we do not need any help at this stage, so please do not send us unsolicited agency resumes. This is not a great use of your time, and we will not accept any liability or fees for any resumes or candidates which we have not asked you to find for us.