Cra Ii
vor 7 Monaten
A global CRO is looking to hire experienced CRAs (CRA II or Senior CRAs) to join them on a permanent basis in Germany.
Working across therapeutic areas, and covering the full life-cycle of clinical trials, the CRA will be responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies in phase II-IV, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
**The role**:
- Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
- Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
- Balancing sponsor generated queries
- Taking responsibility for study cost efficiency
- Preparation and review of study documentation and feasibility studies for new proposals
- Potential to assist in training and mentoring fellow CRAs
**You will need**:
- 18 months+ of monitoring experience in phase I-IV trials as a CRA
- College degree in medicine, science, or equivalent
- Previous monitoring experience in medium-sized studies, including study start-up and close-out
- Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
- Excellent written and verbal communication in English and German language
- Ability to work to tight deadlines
- Availability to travel - approximately 8 monitoring visits per month
- Applicants should possess a valid driving license
**Job Types**: Full-time, Permanent
Ability to commute/relocate:
- Frankfurt: Reliably commute or planning to relocate before starting work (required)
Work Location: In person
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