CRA I/II - SR CRA I

Thermo Fisher Scientific; United States; On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company is seeking a Clinical Trial Monitor responsible for overseeing investigator sites through a risk-based approach. The role involves ensuring compliance with protocols, accurate data reporting, and proactive communication with investigative teams. Ideal candidates possess strong analytical skills and experience in clinical trials, with the ability to manage project compliance effectively. This position offers competitive compensation and a supportive work environment.

Qualifications

• Experience in risk-based monitoring and ensuring compliance.
• Strong analytical and reporting skills.
• Familiarity with clinical trial processes and regulatory requirements.

Responsibilities

• Monitors investigator sites and ensures compliance with protocols.
• Document observations and escalate issues to management.
• Facilitate communication between investigative sites and internal teams.

Skills

Critical thinking

Problem-solving

Root-cause analysis

Compliance

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

* Monitors investigator sites using a risk-based monitoring approach, applying root-cause analysis (RCA), critical thinking, and problem-solving skills to identify site process failures and implement corrective/preventive actions to ensure compliance and reduce risks. Ensures data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring activities.

* Assesses investigational products through physical inventory and records review.

* Documents observations in reports and letters promptly, following approved business writing standards. Escalates deficiencies and issues to clinical management and follows through to resolution. Maintains regular contact with investigative sites between visits to ensure protocol adherence, resolution of previous issues, and timely data recording. Conducts monitoring tasks as per the approved monitoring plan.

* Participates in the investigator payment process. Collaborates with the project team to resolve issues/findings. Investigates and follows up on findings as applicable. Attends investigator meetings as needed. Assists in identifying potential investigators in collaboration with the client to ensure site qualification. Initiates clinical trial sites according to procedures, ensuring compliance with protocol, regulatory, and ICH GCP standards. Manages trial close-out and retrieval of trial materials.

* Ensures completeness and accuracy of essential documents in accordance with ICH-GCP and regulations. Performs on-site file reviews as specified.

* Provides trial status updates and progress reports. Ensures study systems are complete, accurate, and up-to-date, e.g., Clinical Trial Management System.

* Facilitates communication between investigative sites, the client, and internal teams via written, oral, and electronic means. Responds to regulatory requirements, audits, and inspections.

* Contributes to project publications and tools, sharing ideas and suggestions with team members.

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

* Supports process improvement initiatives and other project work as needed.