Proclinical is seeking a Clinical Research Associate to ensure clinical study sites adhere to protocols and guidelines, focusing on oncology trials. The successful candidate will be crucial in facilitating patient recruitment and maintaining compliance with regulatory standards.
Responsibilities:
1. Ensure clinical trials are conducted in compliance with protocols, SOPs, and ICH/GCP guidelines.
2. Conduct site initiation, monitoring, and close-out visits across various study phases.
3. Develop and implement patient recruitment strategies at the site level.
4. Identify and address site needs and issues, providing solutions to facilitate trial processes.
5. Ensure accurate safety reporting and track adverse events.
6. Assist in audit preparations and resolve findings.
7. Build and maintain professional relationships with investigators and site staff.
Key Skills and Requirements:
8. Degree in a relevant field (BA/BS/BSc or similar).
9. Familiarity with ICH/GCP guidelines and local codes of practice.
10. Experience or training as a Clinical Research Associate.
11. Proficiency in English and German.
12. Willingness to travel.
13. Proficient in common software packages.
14. Strong flexibility and teamwork skills.