Clinical Research Associate, Level II/Senior

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

📋 Description

• Execute and oversee clinical monitoring and site management tasks.

• Carry out remote or in-person visits to evaluate adherence to protocols and regulatory standards while managing documentation.

• Utilize risk-based monitoring, root cause analysis, critical thinking, and problem-solving techniques to pinpoint site issues and implement corrective/preventive measures.

• Ensure data integrity through the review of source documents, source data verification, and case report form evaluations.

• Evaluate the inventory and records of investigational products.

• Record observations and escalate issues until resolution is achieved.

• Maintain communication with investigative sites between monitoring visits.

• Perform monitoring activities in accordance with approved plans.

• Engage in investigator payment processes and attend investigator meetings.

• Identify prospective investigators and initiate clinical trial sites.

• Conduct trial closeout activities and retrieve trial materials.

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

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

• Update study systems, including Clinical Trial Management Systems.

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

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

• Complete expense reports and timesheets.

• Assist with project publications, tools, process enhancements, and other project initiatives.

⛳️ Requirements

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

• A minimum of 1 year of experience as a clinical research monitor, or successful completion of the PPD Drug Development Fellowship.

• A valid driver's license if applicable.

• Combinations of education, training, and directly related experience may be considered.

• Demonstrated clinical monitoring abilities.

• Knowledge of medical/therapeutic domains and medical terminology.

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

• Understanding of Risk-Based Monitoring.

• Skills in root cause analysis and problem-solving.

• Strong oral and written communication capabilities.

• Customer-centric approach, active listening skills, and meticulous attention to detail.

• Organizational and time management proficiency.

• Strong interpersonal skills.

• Flexibility and adaptability in various situations.

• Ability to work both independently and collaboratively within a team.

• Proficiency in Microsoft Office and willingness to learn necessary software.

• Competent English language and grammar skills.

• Effective presentation skills.

• Willingness and ability to travel frequently, typically 60–80%, including potential overnight stays.

• Capability to work in environments with possible exposure to biological fluids and infectious organisms while using required personal protective equipment.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements.

• Competitive salary and performance-based incentives.