Sr CRA (Level I)

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

Job summary

A leading company in life sciences is seeking a Clinical Research Monitor to oversee investigator sites. The role involves ensuring compliance through monitoring, assessing investigational products, and maintaining communication with sites. Candidates should have a relevant degree and experience in clinical research monitoring.

Qualifications

• 2+ years of experience as a clinical research monitor or similar role.
• Valid driver’s license if applicable.

Responsibilities

• Monitors investigator sites with a risk-based monitoring approach.
• Assures data accuracy through SDR, SDV, and CRF review.
• Maintains contact with investigative sites for protocol adherence.

Skills

Critical Thinking

Problem Solving

Root Cause Analysis

Education

Bachelor's degree in a life sciences-related field

Registered Nursing certification

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Essential Functions

Monitors investigator sites with a risk-based monitoring approach: applies 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 confirm protocol adherence, resolution of previous issues, and timely data recording. Conducts monitoring in accordance with the approved plan. Participates in the investigator payment process and collaborates with the project team on issue resolution.

Provides trial status updates to the Clinical Team Manager (CTM) and ensures study systems (e.g., CTMS) are updated. Performs QC checks on reports generated from CTMS. Participates in investigator meetings as needed.

Identifies potential investigators with the client to ensure site suitability. Initiates clinical trial sites following relevant procedures, ensuring protocol and regulatory compliance. Manages trial close-out and retrieval of materials. Ensures completeness of essential documents per ICH-GCP and regulations, conducting on-site file reviews as specified.

Contributes to project team activities, including preparing publications/tools and sharing ideas. Performs additional tasks assigned by CTM, such as trip report reviews and team calls.

Facilitates communication among investigative sites, the client, and the project team via written, oral, and electronic means. Responds to audits, inspections, and regulatory requirements. Completes administrative tasks like expense reports and timesheets timely. Supports process improvements and other project initiatives.

Qualifications: Education and Experience

Bachelor's degree in a life sciences-related field or Registered Nursing certification or equivalent, with relevant academic/vocational qualifications. Prior experience of at least 2 years as a clinical research monitor or similar role. Valid driver’s license if applicable.

Working Conditions and Environment

Work is performed in office, laboratory, clinical, or home environments, with exposure to electrical equipment. Frequent travel to site locations (60-80%) with potential overnight stays. Exposure to biological fluids and infectious organisms, requiring personal protective equipment such as eyewear, garments, and gloves. Rare exposure to extreme temperatures.