CRA II: Site Monitoring & Compliance Expert

Linical; Florida; On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

PTO

Comprehensive benefits

Job summary

Linical is seeking a Clinical Research Associate II to oversee feasibility, initiation, monitoring, and close-out of investigative sites. You will ensure participant safety, GCP compliance, data integrity, and proper IP handling across studies.

Reporting to the Senior Manager of Site Management and Monitoring, you will travel up to 75% to sites, qualify and initiate sites, monitor visits, resolve data queries, and support TMF documentation while maintaining regulatory standards.

Qualifications

• Thorough knowledge of clinical research processes, GCPs, and regulatory requirements.
• Excellent written and verbal communication, time management, and organization.
• Fluent in local language and proficient English comprehension.
• Strong interpersonal skills for matrixed teams.
• Commitment to quality across all tasks and deliverables.
• Ability to prioritize multiple tasks, including travel.
• Working knowledge of computer systems and software.
• Willingness to travel up to 75%.
• Valid driver’s license as required.

Responsibilities

• Identify potential investigative sites and conduct site qualification visits; prepare reports and documentation.
• Conduct site initiation visits; train site personnel on regulatory requirements and study conduct.
• Perform site monitoring visits and follow-up to ensure study compliance and data integrity.
• Review on-site files, CRFs, and source documents for accuracy and compliance; initiate corrective actions.
• Assist in submissions to ethics committees and regulatory authorities as needed.
• Arrange site payments and facilitate budgets and contracts.
• Ensure training is current and protocol deviations are documented.
• Manage site monitoring schedules and maintain ongoing site communication.

Skills

Clinical trial process

Communication skills

Local language fluency

People skills

Quality assurance

Task prioritization

Computer skills

Travel readiness

Driver’s license

Education

Life Science degree

Nursing background

CRA training program/experience

Monitoring and site management experience

Job description

Linical is seeking a Clinical Research Associate II to oversee feasibility, initiation, monitoring, and close-out of investigative sites. You will ensure participant safety, GCP compliance, data integrity, and proper IP handling across studies.

Reporting to the Senior Manager of Site Management and Monitoring, you will travel up to 75% to sites, qualify and initiate sites, monitor visits, resolve data queries, and support TMF documentation while maintaining regulatory standards.