CRA II - Senior CRA

at  AL Solutions

Client Overview: Our client is a leading global Contract Research Organization (CRO) providing full-service clinical development solutions for pharmaceutical, biotech, and medical device companies.

JOB SUMMARY:

We are currently seeking multiple experienced Senior Clinical Research Associates to join our client’s expanding Clinical Operations team in Germany. The Sr. CRA will be responsible for ensuring the successful execution of clinical trials, including site selection, initiation, monitoring, and close-out activities. The ideal candidate will have strong leadership skills, excellent communication and organizational abilities, and a proven track record of successful clinical trial management.

REQUIREMENTS:

• Thorough knowledge of ICH-GCP guidelines, local regulations, and industry best practices.
• Strong leadership skills and the ability to manage multiple projects simultaneously.
• Excellent communication and interpersonal skills, with the ability to effectively communicate with internal and external stakeholder

• Oversee clinical trial activities at assigned sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and local regulatory requirements.
• Perform site selection and initiation visits, including site feasibility assessments, site qualification visits, and site initiation visits.
• Conduct monitoring visits to assess site performance, including source data verification, study drug accountability, and safety reporting.
• Manage study timelines and budgets, ensuring that clinical trial milestones are met on time and within budget.
• Maintain accurate and up-to-date study documentation, including study binders, case report forms, and regulatory documents.
• Provide guidance and training to junior CRA team members, ensuring that study procedures are followed consistently across all sites.
• Communicate effectively with study sponsors, investigators, and study coordinators, ensuring that all parties are informed of study progress and issues.