Clinical Research Associate II – Sponsor-Dedicated FSP

This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversee investigator sites utilizing a risk-based monitoring strategy

• Utilize root cause analysis, critical thinking, and problem-solving techniques to pinpoint site process failures and implement corrective or preventive measures

• Ensure the accuracy of data through thorough reviews of source documents, source data verification, and CRF examinations

• Evaluate investigational product inventory and maintain accurate records

• Record observations in reports and letters, escalating any deficiencies to clinical management

• Keep in touch with investigative sites between monitoring visits and address any issues that arise

• Execute monitoring tasks in line with the approved monitoring plan

• Engage in investigator payment processes and resolve any related issues

• Take part in investigator meetings

• Identify potential investigators and initiate clinical trial sites

• Conduct trial closeout procedures and retrieve trial materials

• Ensure that essential documents are complete and perform on-site file reviews

• Provide trial status tracking and updates on progress to the Clinical Team Manager

• Update study systems in accordance with established conventions

• Facilitate communication between investigative sites, the client company, and the PPD project team

• Address company, client, and regulatory requirements, including audits and inspections

• Complete expense reports and timesheets

• Assist with project publications and tools, contributing ideas to the project team

• Contribute to initiatives aimed at process improvement

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification or an equivalent formal academic/vocational qualification

• Minimum of 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship

• Valid driver's license where applicable

• Equivalent combinations of education, training, and relevant experience may be considered

• Demonstrated skills in clinical monitoring

• Familiarity with medical/therapeutic areas and medical terminology

• Working knowledge of ICH-GCP, applicable regulations, and procedural documentation

• Strong critical thinking, root cause analysis, investigative, and problem-solving abilities

• Capability to manage risk-based monitoring concepts and processes

• Excellent oral and written communication skills

• Customer-oriented with strong listening skills and attention to detail

• Proficient organizational and time management skills

• Effective interpersonal skills

• Flexibility and adaptability to changing situations

• Ability to work independently or collaboratively within a team

• Strong knowledge of Microsoft Office and the capacity to learn relevant software

• Proficient English language and grammar skills

• Strong presentation abilities

• Willingness to travel frequently, typically 60–80%, with potential for extended overnight stays

• Capability to work in environments with possible exposure to biological fluids and infectious organisms

• Ability to utilize required personal protective equipment

🏝️ Benefits

• Fully remote work arrangement

• Standard Monday–Friday work schedule

• Opportunities for rewarding career growth and professional development through work in the life sciences, diagnostics, and therapies sectors

• Reasonable accommodations available for individuals with disabilities

• Equal employment opportunity