Senior Clinical Research Associate

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

📋 Description

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

• Guarantees data integrity through Site Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) evaluations as relevant via on-site and remote monitoring activities.

• Evaluates investigational products through physical inventory assessments and record reviews.

• Timely documents findings in reports and correspondence adhering to established business writing standards.

• Promptly escalates identified deficiencies and concerns to clinical management, ensuring all issues are tracked to resolution.

• May need to maintain ongoing communication between monitoring visits with investigative sites to validate adherence to the protocol, confirm resolution of previously identified issues, and ensure timely data recording.

• Executes monitoring responsibilities in alignment with the sanctioned monitoring plan.

• Engages in the investigator payment process.

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

• Investigates and follows up on findings as necessary.

• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as needed.

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

• Conducts quality control checks of reports generated from the CTMS system where necessary.

• Participates in investigator meetings as required.

• Identifies potential investigators in collaboration with the client company to confirm the acceptability of qualified investigative sites.

• Initiates clinical trial sites following relevant procedures to assure compliance with the protocol and regulatory and ICH GCP obligations, offering recommendations when appropriate.

• Oversees trial closeout and retrieval of trial materials.

• Ensures essential documents are complete and in place according to ICH-GCP and applicable regulations.

• Conducts on-site file reviews following project specifications.

• Contributes to the project team by aiding in the preparation of project publications/tools and sharing ideas/suggestions with team members.

• Performs additional study tasks as assigned by the CTM (e.g., trip report review, newsletter creation, leading CRA team calls, etc.).

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

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

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

• Contributes to other project work and initiatives aimed at process improvement as necessary.

⛳️ Requirements

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

• Prior experience that provides the knowledge, skills, and abilities necessary to perform the role (comparable to 5+ years as a clinical research monitor).

• Valid driver's license where applicable.

• In certain instances, an equivalency that combines appropriate education, training, and/or directly related experience may be considered adequate for an individual to fulfill the role's requirements.

🏝️ Benefits

• Flexible work arrangements.

• Professional development opportunities.