Clinical Research Associate

About the Role

We are collaborating with a prominent clinical research organization located in Germany to fill the position of Clinical Research Associate (CRA). This mid-sized Contract Research Organization (CRO) has demonstrated exceptional performance through its strong portfolio of repeat clients, multi-sponsor investigations, and recognized quality delivery. The role involves onsite monitoring and offers substantial career advancement within a company that values its employees.

The organization combines the robustness and reliability of a leading CRO with the close community feel and independence typical of a mid-sized enterprise.

Primary Responsibilities

• Oversee and manage clinical trial sites assigned, serving as the main point of contact for these locations.
• Carry out site monitoring activities such as Pre-Study Visits (PSV), Site Initiation Visits (SIV), routine monitoring visits, and study close-out visits.
• Ensure all clinical trials strictly adhere to protocols, International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines, regulatory mandates, and Standard Operating Procedures (SOPs).
• Assist in site start-up initiatives including feasibility assessments and site selection processes.
• Review and upkeep essential regulatory and trial documentation.
• Track patient recruitment, evaluate site performance, and manage investigational product accountability effectively.
• Keep the project team regularly informed about site progress and actively contribute to the success of clinical studies.

Candidate Requirements

• Proven clinical research experience with independent site monitoring conducted in Germany.
• Educational background in Life Sciences or a comparable field.
• Comprehensive understanding of ICH-GCP principles and regulatory frameworks.
• Proficiency in German and English languages, both written and oral.
• Strong organizational abilities combined with excellent communication skills.

Benefits and Work Environment

• Work within a globally networked and cooperative clinical research setting.
• Access to significant professional growth opportunities and career development paths.
• Flexible work schedules supported by a collaborative and encouraging team.
• Engage in innovative clinical research efforts that aim to enhance patient care outcomes.
• Participate in incentive bonus programs that share business achievements directly with team members.