CRA - FSP

Proclinical is seeking a dedicated and experienced Clinical Research Associate II for a leading global pharmaceutical company specializing in in-vitro diagnostics. The successful candidate will be responsible for designing, planning, coordinating, and conducting activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

Responsibilities:

• Conduct site visits (selection, initiation, monitoring, and close-out) per contracted scope of work and regulatory requirements.
• Collaborate with sites to develop and track subject recruitment plans.
• Provide protocol and study training to sites and establish regular communication to manage project expectations and issues.
• Assess the quality and integrity of site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment and enrolment, CRF completion, and data query resolution.
• Assist with the start-up phase as required.
• Ensure site documents are available for the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) complies with GCP and local regulations.
• Maintain site management documentation, submit visit reports, generate follow-up letters and complete other required study documentation.
• Work with study team members to support project execution.
• Support the development of project subject recruitment plans on a per-site basis.
• Manage site financials according to the executed clinical trial agreement and retrieve invoices as per local requirements.

Key Skills and Requirements:

• Bachelor's degree in a scientific field. A degree in medical technology is preferred but not required if R&D background is adequate.
• Knowledge of clinical research regulatory requirements (GCP and ICH guidelines).
• Good therapeutic and protocol knowledge.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Proficiency in using a laptop computer and iPhone/iPad (where applicable).
• Strong written and verbal communication skills in English, German a plus.
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

If you are having difficulty in applying or if you have any questions, please contact Felix Zimmer on f.zimmer@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.