Job Title: Clinical Research Associate (CRA) - Medical Device (m/f/d)
Schedule: Home-based, open also for freelancers (0.5 FTE)
Permanent position responsible for full site management from site selection to close out of clinical studies.
Therapeutic areas of the studies: Epilepsies, Pain, Tinnitus. Clinical sites are all over in Germany.
Precisis is a well-funded startup, developing neuromodulation technologies focused on functional brain diseases, specifically epilepsy and neuropathic pain. Minimal invasiveness and precise targeting of stimulation therapy pose distinct advantages over currently available technologies in the market and are the foundation of Precisis projects. Our first product, the EASEE® System, is currently under clinical evaluation and will be launched in 2021.
The Precisis team of 15 consists of experienced and entrepreneurial-minded individuals with the common goal of bringing to the market next generation neuromodulation solutions.
Main Tasks and Responsibilities
- Assist in the selection of sites, conduction of site qualification visits and site initiation visits, and collection of pre-study documentation to ensure efficient study start-up
- Perform training of site staff on all study procedures to ensure protocol/ICH-GCP compliance
- Conduct and report on periodic monitoring visits in the field, reviewing accuracy, legibility, completeness, and quality of Case Report Form (CRF) in compliance with the protocol, SOPs and ICH-GCP requirements to ensure data integrity and subject safety
- Cooperate closely with site staff to ensure correct and timely reporting of safety issues (AEs/SAEs, etc.) and their follow up
- Maintain close contact with the investigators, study coordinators and other involved parties on-site
- Anticipate, recognize, and resolve issues at the study sites, escalate any issues to relevant project team members
- May assist in contract negotiation with sites on study budget after appropriate and documented training
- May support the EC & CA submission process for various projects and regions
Education and Experience
- Degree in scientific medical or paramedical discipline or an equivalent combination of education and work experience
- Prior experience as a CRA, minimum 4 years
- Experience in Medical Device studies
- Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirements
- Fluency in English and German
- Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
- Willingness to travel
If you have any questions, please contact us at +49 6221 6559300.
Please send your collected application documents in pdf-form to firstname.lastname@example.org.