Sub Investigator

Velocity Clinical Research, Inc.; Hamburg; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Velocity Clinical Research in Hamburg is seeking a Sub Investigator to support the Principal Investigator in safe, ethical, and compliant clinical trials. You will perform delegated medical activities, assess participants, determine eligibility, ensure safety, and document care under GCP and GDPR.

Fluency in German and good English, a German medical licence (Approbation), and strong clinical judgement are required to deliver high quality data and patient care in a regulated research setting.

Qualifikationen

• 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.
• Fluency in German and professional proficiency in English.

Aufgaben

• Perform delegated clinical trial activities in accordance with study protocols, ICH-GCP, EU 536/2014, AMG, and SOPs.
• Clinically evaluate study participants and address trial-related medical issues.
• Review medical history, concomitant medications, and protocol inclusion/exclusion criteria.
• Determine participant eligibility and document clinical assessments appropriately.
• Assess participant response to therapy and compliance with investigational medicinal product requirements.
• Administer investigational products within delegated authority and scope of practice.
• Escalate adverse events and SAE per protocol and regulatory requirements.
• Ensure medical care for participants with adverse events or significant findings.
• Support participant recruitment and pre-screening activities.
• Support informed consent process per ethics approvals and GCP requirements.
• Participate in sponsor, CRO, regulatory, and audit/inspection activities as required.
• Maintain participant confidentiality per GDPR, BDSG, and company requirements.
• Complete clinical and administrative documentation per GCP and SOPs.

Kenntnisse

Clinical medicine

GCP knowledge

Medical safety management

German & English

Communication & teamwork

Ausbildung

Approbation (Germany)

GCP training

5+ years clinical practice

Jobbeschreibung

Overview

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Summary:

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.

Responsibilities

Duties/Responsibilities

• 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.

Qualifications

Required Skills/Abilities:

• 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.

Education and Experience:

• 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.

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.