Clinical Research Associate, Various Levels

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

📋 Description

• Perform remote or on-site evaluations to ensure compliance with protocols and regulations, managing all necessary documentation.

• Oversee procedures and guidelines from various sponsors and/or monitoring environments.

• Guarantee that the trial is executed in line with the approved protocol, ICH-GCP guidelines, relevant regulations, and SOPs to protect subjects' rights, well-being, and data integrity.

• Maintain audit preparedness and cultivate collaborative relationships with investigational sites.

• Utilize a risk-based monitoring strategy to oversee investigator sites.

• Implement root cause analysis (RCA), critical thinking, and problem-solving techniques to identify failures in site processes and develop corrective/preventive actions.

• Ensure data accuracy through SDR, SDV, and CRF reviews.

• Promptly escalate identified deficiencies and issues to clinical management and track all issues to resolution.

• Keep in regular contact with investigative sites between monitoring visits to confirm adherence to the protocol, address previously identified issues, and ensure timely data recording.

• Carry out monitoring tasks as outlined in the approved monitoring plan.

• Engage in investigator meetings and assist in identifying potential investigators in partnership with the client company.

• Initiate clinical trial sites in accordance with relevant procedures.

• Execute trial closeout and the retrieval of trial materials.

• Verify that all essential documents are complete and compliant with ICH-GCP and applicable regulations.

• Provide trial status tracking and progress update reports to the team as necessary.

• Facilitate effective communication between investigative sites, the client company, and internal project teams through written, verbal, and/or electronic means.

• Timely complete administrative tasks, such as expense reports and timesheets.

⛳️ Requirements

• Minimum of 2 years of experience.

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

• Basic clinical monitoring experience that equips the candidate with the knowledge, skills, and capabilities to perform the job (equivalent to 2 years) in a clinical setting, where experience is obtained in clinical trials, medical terminology, medical research, clinical research, or healthcare; experience in a health sciences field with formal training in medical terminology and anatomy may also be acceptable.

• Valid driver’s license where applicable.

• Fundamental knowledge of medical/therapeutic areas and understanding of medical terminology.

• Capability to acquire and maintain a working knowledge of ICH GCPs and relevant regulations and procedural documents.

• Strong oral and written communication skills, with the ability to effectively engage with medical personnel.

• Excellent interpersonal skills.

• Ability to focus on customer needs by utilizing effective listening skills, attention to detail, and perceiving underlying customer issues.

• Strong organizational and time management abilities.

• Flexibility and adaptability in a variety of scenarios.

• Well-honed critical thinking skills, including, but not limited to, a critical mindset, thorough investigation for appropriate root cause analysis, and problem-solving.

• Proficiency in managing Risk-Based Monitoring concepts and processes.

• Ability to work collaboratively in a team or independently as necessary.

• Proficient computer skills: solid knowledge of Microsoft Office and the ability to learn relevant software applications.

• Good command of the English language and grammar.

🏝️ Benefits

• Competitive salary.

• Flexible working hours.

• Professional development budget.

• Home office setup allowance.

• Global team events.