Sub Investigator

The Sub Investigator supports the Principal Investigator in the safe, ethical, and compliant conduct of clinical trials. The role is responsible for delegated medical activities including participant assessment, eligibility determinations, safety oversight, accurate clinical documentation, and appropriate medical care while ensuring participant safety, rights, and well-being.

• Perform delegated clinical trial activities in accordance with study protocols, ICH-GCP, Regulation (EU) No 536/2014, applicable requirements of the German Medicinal Products Act (Arzneimittelgesetz - AMG), and Company SOPs.
• Clinically evaluate study participants and address trial-related medical issues during study visits.
• Review medical history, concomitant medications, and protocol inclusion and exclusion criteria.
• Determine participant eligibility and document clinical assessments appropriately.
• Assess participant response to therapy and compliance with investigational medicinal product requirements.
• Administer investigational medicinal products, including intravenous, subcutaneous, and oral therapies, within delegated authority and professional scope of practice.
• Evaluate, treat, document, and escalate adverse events and serious adverse events in accordance with protocol and regulatory requirements.
• Ensure appropriate medical care is available for participants experiencing adverse events or clinically significant findings.
• Support participant recruitment and clinician-led pre-screening activities.
• Support the informed consent process in accordance with ethics committee approvals and GCP requirements.
• Participate in sponsor, CRO, regulatory authority, and audit or inspection activities as required.
• Maintain participant confidentiality in accordance with GDPR, the German Federal Data Protection Act (BDSG), and Company requirements.
• Complete clinical and administrative documentation in accordance with GCP and Company SOPs.

• Thorough knowledge of clinical medicine and participant safety management.
• Working knowledge of ICH-GCP, EU Clinical Trial Regulation requirements, and clinical research documentation standards.
• Ability to evaluate medical history, clinical findings, protocol criteria, and medication use.
• Strong clinical judgement, professionalism, teamwork, and communication skills.
• Ability to complete sponsor and protocol-specific training requirements within established timelines.
• Fluency in German and professional proficiency in English.
• Licensed physician (Arzt/Ärztin) authorised to practice medicine in Germany.
• Valid medical licensure through the appropriate German regulatory authority (Approbation).
• Five or more years of relevant clinical practice or equivalent clinical research experience.
• Previous clinical research experience preferred.
• Required Licences and Certifications
• Current German medical licence (Approbation).
• Current GCP training certification or willingness to obtain promptly.