Clinical Research Associate II/Sr. Clinical Research Associate

Jobtailor; Deutschland; Hybrid; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced Clinical Site Monitor for Germany to manage investigator sites through activation, monitoring, and close-out while ensuring patient safety and compliance with GCP and sponsor standards. The role requires strong communication with study teams and site personnel, plus hands-on training and coaching.

Ideal candidates will have a life sciences background, at least 2 years in site monitoring, fluency in English and German, and the ability to travel 60–80%.

Qualifikationen

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations.
• Minimum 2 years of relevant experience in clinical research site monitoring.
• Fluent in English and German.
• Ability to travel 60–80%.
• Valid driver’s license and passport required.
• Bachelor’s degree in life sciences or equivalent.

Aufgaben

• Manage site management, monitoring, and close-out of assigned clinical trial investigator sites.
• Ensure patient safety and quality study execution according to applicable laws, GCP, and sponsor standards.
• Manage investigator site relationships from site activation through database lock.
• Serve as primary contact for assigned investigator sites and collaborate with study teams.
• Facilitate information flow among study team members and investigator sites.
• Train and coach site personnel on protocols and compliance.
• Support site activation, recruitment, enrollment, and investigator meetings.
• Conduct onsite and remote/electronic monitoring activities.

Kenntnisse

English (Fluent)

German (Native)

Travel 60-80%

Ausbildung

Bachelor’s degree in Life Sciences

Jobbeschreibung

• Manage site management, monitoring, and close-out of assigned clinical trial investigator sites
• Ensure patient safety and quality study execution according to applicable laws, GCP, and sponsor standards
• Manage investigator site relationships and operational aspects from site activation through database lock
• Serve as primary contact for assigned investigator sites and collaborate with Site Care Partners and study teams
• Facilitate information flow among study team members, vendors, and investigator sites
• Train and coach site personnel on protocols and compliance
• Support site activation, patient recruitment, enrollment, and investigator meetings
• Conduct onsite and remote/electronic site initiation, routine monitoring, and close-out activities
• Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
• Submit TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management, study progress, and metrics
• Identify and resolve site issues and develop corrective and preventive actions
• Resolve data queries and prepare and conduct site close-out activities
• Oversee investigational product receipt, handling, accounting, storage, and destruction
• Support database release and perform unblinded monitoring when appropriate
• Maintain product, protocol, and therapy-area knowledge and support patient safety and clinical guidance
• Drive Quality Event remediation and audit observation CAPA activities when applicable

Requirements

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations
• Minimum 2 years of relevant experience in clinical research site monitoring
• Fluent in English and the native language(s) of the country of work
• Ability to travel 60–80%
• Valid driver’s license and passport required
• Bachelor’s degree in life sciences, or professional degree in life sciences such as nursing, pharmacy, or medical background, or equivalent
• Ability to conduct onsite and remote/electronic monitoring
• Knowledge of protocol, therapy area, patient safety, eligibility, and clinical guidance
• Location specified as United States/Arizona/Remote United States

Core Competencies

Demonstrates extensive knowledge of clinical trial methodologies, ICH/GCP, and FDA regulations, with a strong focus on patient safety and quality study execution. Proficient in managing investigator site relationships and conducting both onsite and remote monitoring activities.

Highest-signal resume keywords

• Clinical Trial Methodologies
• ICH/GCP Compliance
• Site Monitoring Experience
• Patient Safety Management
• Fluent in English

ATS Optimization Keywords

Hard Skills

• Clinical Trial Management
• Site Activation
• Patient Recruitment
• Protocol Compliance
• Data Query Resolution
• Adverse Event Monitoring
• TMF Documentation
• CAPA Activities
• Remote Monitoring
• Investigational Product Handling

Soft Skills

• Collaboration
• Training and Coaching
• Problem Solving
• Communication

Certifications & Qualifications

• Bachelor’s Degree in Life Sciences
• Valid Driver’s License
• Passport

Industry Keywords

• Clinical Research
• FDA Regulations
• GCP Standards
• Site Management
• Investigator Meetings