Senior Clinical Research Associate (m/w/d)

Computer Futures; München; Hybrid; EUR 70,000 - 90,000; Full time

Job summary

Computer Futures in Munich is seeking a Senior Clinical Research Associate (m/w/d) for a permanent, full-time position in a hybrid setting. You will independently conduct monitoring visits, SDV/SDR, and CRF reviews across Phase II and III trials, ensuring data integrity and patient safety.

You will act as the primary contact for investigational sites, help with site identification and activation, and collaborate with cross-functional teams including Trial Managers and Medical Monitors.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Medicine, or a related field.
• Independent monitoring experience within Germany.
• Experience conducting all major monitoring visit types across Phase II and/or Phase III clinical trials.
• Strong understanding of ICH-GCP, EU Clinical Trial Regulations, and clinical trial operations.
• Excellent communication and stakeholder management skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Professional proficiency in both German and English.
• Proficient in Microsoft Office applications.
• Valid driver's license and willingness to travel regularly within Germany.

Responsibilities

• Independently conduct all types of monitoring visits (SSVs, SIVs, Routine Monitoring Visits, COVs, Remote Monitoring).
• Perform SDV, SDR, and CRF review.
• Ensure timely resolution of data queries and site-related issues.
• Act as the primary point of contact for assigned investigational sites.
• Support site identification, feasibility, and activation activities.
• Maintain study documentation in compliance with ICH-GCP, local regulations, and SOPs.
• Monitor patient safety, protocol compliance, and data integrity.
• Collaborate with Clinical Trial Managers, Project Managers, Medical Monitors, and cross-functional study teams.
• Support and mentor less experienced CRAs where appropriate.
• Contribute to study planning, site performance management, and overall study delivery.

Skills

Independent monitoring experience (GER

Education

Bachelor's degree in Life Sciences, Nursing, Pharmacy, Medicine or related field

Tools

Microsoft Office

Job description

Senior Clinical Research Associate (m/w/d)

Location: München / hybrid

Employment Type: Permanent / Full-time

Key Responsibilities

• Independently conduct all types of monitoring visits, including:
• Site Selection Visits (SSVs)
• Site Initiation Visits (SIVs)
• Routine Monitoring Visits
• Close-Out Visits (COVs)
• Remote Monitoring Visits
• Perform Source Data Verification (SDV), Source Data Review (SDR), and CRF review.
• Ensure timely resolution of data queries and site-related issues.
• Act as the primary point of contact for assigned investigational sites.
• Support site identification, feasibility, and activation activities.
• Maintain study documentation in compliance with ICH-GCP, local regulations, and SOPs.
• Monitor patient safety, protocol compliance, and data integrity.
• Collaborate closely with Clinical Trial Managers, Project Managers, Medical Monitors, and cross-functional study teams.
• Support and mentor less experienced CRAs where appropriate.
• Contribute to study planning, site performance management, and overall study delivery.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, Medicine, or a related field.
• Independent monitoring experience within Germany.
• Experience conducting all major monitoring visit types across Phase II and/or Phase III clinical trials.
• Strong understanding of:
• ICH-GCP
• EU Clinical Trial Regulations
• Clinical trial operations and compliance requirements
• Excellent communication and stakeholder management skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Professional proficiency in both German and English.
• Proficient in Microsoft Office applications.
• Valid driver's license and willingness to travel regularly within Germany.