Senior Clinical Research Associate I, Sponsor-Dedicated FSP

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

📋 Description

• Oversee investigator sites utilizing a risk-based monitoring strategy.

• Implement root-cause analysis, critical thinking, and problem-solving techniques to pinpoint site-process failures and necessary corrective/preventive measures.

• Guarantee data integrity through comprehensive source document evaluation, source data verification, and CRF analysis.

• Evaluate investigational product inventory and associated records.

• Record observations in reports and letters, and escalate issues until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Execute monitoring responsibilities in accordance with the approved monitoring plan.

• Engage in investigator payment processes and resolution of findings.

• Monitor trial status and provide updates on progress to the Clinical Team Manager.

• Refresh and conduct quality checks on study systems, including CTMS.

• Attend investigator meetings and identify qualified investigators/sites.

• Initiate clinical trial sites and ensure the trial's closure and retrieval of trial materials.

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

• Assist with project publications/tools and other study-related tasks.

• Foster communication among investigative sites, the client company, and the project team.

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

• Complete expense reports and timesheets.

• Participate in process-improvement initiatives.

⛳️ Requirements

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

• A minimum of 2 years of experience as a clinical research monitor or in a comparable role.

• Valid driver's license when applicable.

• Equivalence may be achieved through a combination of suitable education, training, and directly related experience.

• Proficient clinical monitoring skills.

• Knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with and application of ICH GCPs, relevant regulations, and procedural documents.

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

• Capacity to manage risk-based monitoring concepts and processes.

• Effective oral and written communication skills with medical personnel.

• Customer-focused, with excellent listening skills, attention to detail, and the ability to identify underlying issues.

• Strong interpersonal, organizational, and time-management abilities.

• Flexibility and adaptability in various situations.

• Capability to work independently or collaboratively within a team.

• Proficiency in Microsoft Office and the ability to learn necessary software.

• Strong English language and grammar proficiency.

• Presentation skills.

• Compliance with sponsor/client/site requirements, including potential disclosure of vaccination status or other personal information.

• Willingness to travel frequently, typically 60–80%, including frequent drives and possible extended overnight stays.

• Ability to work in office, laboratory, clinical, and/or home-office environments.

• Capability to utilize required personal protective equipment and work with biological fluids and potentially infectious organisms.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Opportunities for professional development and career advancement.

• Reasonable accommodations for individuals with disabilities.

• Equal employment opportunity.