Sub Investigator - Wiesbaden

Overview
A leading clinical research organization is seeking a Sub Investigator to support and conduct clinical trials while ensuring patient safety and data integrity. This role is critical in providing high-quality research data while prioritizing exemplary patient care.

For dedicated professionals who excel in clinical research, this organization offers opportunities for career advancement, competitive benefits, and performance-based rewards. Whether you are new to clinical research or an experienced professional, we encourage you to apply.

Benefits include:

• Medical, dental, and vision insurance
• Paid time off and company holidays
• 401(k) retirement plan with company match
• Annual incentive program

Role Summary

The Sub Investigator is responsible for overseeing the safety and well-being of patients enrolled in clinical trials, ensuring accurate data collection, and providing essential support to the study team. This individual will collaborate closely with Principal Investigators, Clinical Research Coordinators, and other staff to maintain compliance with study protocols and regulatory requirements.

Key Responsibilities

• Lead study teams in executing clinical trials efficiently.
• Mentor and train staff on clinical trial processes, protocol requirements, and regulatory compliance.
• Develop training strategies and risk mitigation plans.
• Oversee clinical trial operations, including patient recruitment, protocol adherence, data entry, and adverse event reporting.
• Apply project management principles to ensure high-quality research and risk management.
• Communicate professionally with sponsors, CROs, vendors, study teams, and patients.
• Ensure proper documentation and confidentiality of patient and sponsor information in compliance with HIPAA and GCP/ICH regulations.
• Implement and maintain quality control strategies to enhance data integrity and research outcomes.
• Perform clinical duties within the scope of licensure (e.g., drug preparation, administration, phlebotomy, ECG, lab processing).
• Evaluate potential subjects for trial eligibility and assist in recruitment efforts.
• Participate in the development of research strategies, study protocols, and site operations to enhance efficiency and compliance.
• Ensure timely resolution of queries and data entry into sponsor systems.
• Support the submission and collection of regulatory documents in compliance with IRB and regulatory requirements.
• Promote diversity and cultural sensitivity in patient care and research.
• Stay updated on disease processes and clinical research advancements.
• Perform additional duties as assigned.

Qualifications & Requirements

• Must hold an active MD, DO, NP, or PA license in the state of practice.
• Completion of sponsor and CRO-mandated training and certifications for clinical trials.
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements .
• Ability to maintain confidentiality and handle sensitive data securely per HIPAA regulations .
• Professionalism, teamwork, and adaptability in a dynamic research environment.
• Strong written and verbal communication skills in English.
• Willingness to travel up to 10% for meetings, presentations, and professional conferences.

Education & Experience

• Licensed MD, DO, NP, or PA required.
• 2+ years of experience in clinical research or clinical management.

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