Clinical Research Associate II – FSP Business Unit

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

📋 Description

• Oversees investigator sites utilizing a risk-based monitoring strategy: employs root cause analysis (RCA), critical thinking, and problem-solving abilities to pinpoint site process failures and implement corrective/preventive measures to ensure compliance and mitigate risks.

• Guarantees data integrity through SDR, SDV, and CRF evaluation as necessary via on-site and remote monitoring efforts.

• Evaluates investigational products through physical inventory checks and records assessments.

• Records observations in reports and correspondence promptly, adhering to authorized business writing standards.

• Quickly escalates identified deficiencies and issues to clinical management, ensuring all matters are followed through to resolution.

• May require maintaining consistent communication with investigative sites between monitoring visits to verify adherence to protocols, resolution of previously identified issues, and timely data recording.

• Executes monitoring activities in line with the approved monitoring plan.

• Engages in the investigator payment process.

• Shares responsibility with fellow project team members for resolving issues and findings.

• Investigates and follows up on relevant findings as necessary.

• Attends investigator meetings as needed.

• Collaborates with the client company to identify potential investigators, ensuring the suitability of qualified investigative sites.

• Initiates clinical trial sites following appropriate procedures to ensure compliance with protocols and regulatory and ICH GCP requirements, offering recommendations when appropriate.

• Conducts trial closeout and retrieves trial materials.

• Confirms that essential documents are complete and organized, adhering to ICH-GCP and relevant regulations.

• Performs on-site file evaluations according to project specifications.

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

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

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

• Addresses company, client, and applicable regulatory requirements/audits/inspections.

• Completes and maintains administrative tasks such as expense reports and timesheets punctually.

• Supports the project team by aiding in the preparation of project publications/tools and contributing ideas and suggestions.

• Participates in other project activities and initiatives aimed at process enhancement, as required.

⛳️ Requirements

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

• Prior experience that equips the knowledge, skills, and abilities necessary for the role (comparable to 1 year as a clinical research monitor) or completion of the PPD Drug Development Fellowship.

• Valid driver's license where necessary.

• Demonstrated clinical monitoring capabilities.

• Proven understanding of medical/therapeutic areas and medical terminology.

• Established ability to acquire and maintain a comprehensive understanding of ICH GCPs, relevant regulations, and procedural documents.

• Highly developed critical thinking skills, including a critical mindset, thorough investigation for effective root cause analysis, and problem-solving.

• Proficient in managing Risk Based Monitoring concepts and methodologies.

• Strong oral and written communication skills, enabling effective interaction with medical professionals.

• Ability to maintain a customer-focused approach through active listening, meticulous attention to detail, and the capacity to recognize underlying customer issues.

• Excellent organizational and time management abilities.

• Strong interpersonal skills.

• Keen attention to detail.

• Flexibility and adaptability in various scenarios.

• Capability to work collaboratively in a team or independently as needed.

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

• Proficient English language and grammar skills.

• Strong presentation abilities.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Paid time off

• Flexible working hours

• Professional development opportunities