Senior Clinical Research Associate

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

📋 Description

• Oversees investigator sites utilizing a risk-based monitoring strategy, employing root cause analysis (RCA), critical thinking, and problem-solving abilities to identify failures in site processes and implement corrective/preventive actions to ensure compliance and mitigate risks.

• Guarantees the accuracy of data through SDR, SDV, and CRF reviews as necessary during both on-site and remote monitoring activities.

• Evaluates investigational products through physical inventory and review of records.

• Records observations in reports and letters promptly, adhering to approved business writing standards.

• Quickly escalates identified deficiencies and issues to clinical management and follows through until resolution.

• May maintain regular communication with investigative sites between monitoring visits to verify adherence to protocols, ensure resolution of previously identified issues, and confirm timely data recording.

• Executes monitoring tasks in line with the established monitoring plan.

• Engages in the investigator payment process.

• Shares responsibility with other project team members in resolving issues and findings.

• Investigates and follows up on findings as necessary.

• Provides updates on potential trends observed across multiple sites and discusses management strategies with the Clinical Team Manager (CTM).

• Participates in investigator meetings as needed and collaborates with the client company to identify potential investigators, ensuring the suitability of qualified investigative sites.

• Initiates clinical trial sites in accordance with relevant procedures to ensure compliance with protocols, regulatory standards, and ICH GCP obligations, making recommendations when appropriate.

• Manages trial closeouts and the retrieval of trial materials.

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

• Conducts on-site file reviews in accordance with project specifications.

• Contributes to the project team by mentoring new members, assisting in the preparation of project publications/tools, including informed consents, CRF guidelines, and monitoring plans, while sharing ideas and suggestions with team members.

• Aids in project-specific training for the clinical team as necessary.

• Identifies potential areas for process improvements and shares solutions for enhancements.

• Undertakes additional tasks as assigned by the CTM or Clinical Manager of CRAs (CM-CRA), such as trip report reviews, newsletter creation, and leading CRA team calls.

• Provides trial status tracking and progress updates to the Clinical Team Manager (CTM) as required.

• Ensures study systems are updated according to agreed study conventions (e.g., Clinical Trial Management System, CTMS).

• Performs quality control checks on reports generated from the CTMS system as necessary.

• Facilitates effective communication among investigative sites, the client company, and the PPD project team through written, oral, and/or electronic interactions.

• Responds to company, client, and relevant regulatory requirements, audits, and inspections as mandated by federal regulations.

• Completes administrative tasks such as expense reports and timesheets promptly.

⛳️ Requirements

• Bachelor's degree in a life science-related field or equivalent formal academic/vocational qualifications.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (comparable to 3+ years as a clinical research monitor).

• Valid driver's license where applicable.

• Proficient clinical monitoring skills.

• Strong understanding and demonstrated application of FDA guidelines, ICH GCPs, relevant regulations, and procedural documents.

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

• Knowledge of Risk-Based Monitoring concepts and processes.

• Ability to mentor and train other monitors effectively and positively.

• Capability to assess medical research data and a strong understanding of medical terminology.

• Ability to maintain customer focus through effective listening skills, attention to detail, and the ability to perceive underlying customer issues.

• Excellent interpersonal skills.

• Strong attention to detail.

• Effective organizational and time management skills.

• Ability to remain flexible and adaptable in diverse scenarios.

• Excellent team player with team-building skills.

• Ability to work independently as needed.

• Ability to utilize problem-solving techniques applicable to a constantly changing environment.

• Proficient computer skills: knowledgeable in Microsoft Office and capable of learning relevant software.

• Strong English language and grammar skills.

• Effective presentation skills.

🏝️ Benefits

• Flexible work arrangements.

• Professional development opportunities.