Sr Clinical Research Associate (CRA)/Principal CRA - Spanish Fluent - FL, GA, KY, NC, OH, TN

Thermo Fisher Scientific - Atlanta, GA

Full-time - Mid Level

Hybrid - Atlanta, GA

Computer and Electronic Product Manufacturing

About the position

The position is for an experienced Clinical Research Associate (CRA) at Thermo Fisher Scientific, focusing on monitoring clinical trials in various therapeutic areas including oncology, cell or gene therapy, ophthalmology, and CNS. The role involves significant travel, both regionally and nationally, to ensure compliance with clinical protocols and regulations, while also fostering relationships with investigational sites. Candidates fluent in Spanish are prioritized for this role, which emphasizes quality, accuracy, and effective communication in clinical research operations.

Responsibilities

• Perform and coordinate all aspects of the clinical monitoring and site management process.
• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation.
• Manage procedures and guidelines from different sponsors and/or monitoring environments.
• Act as a site processes specialist, ensuring compliance with approved protocols and ICH-GCP guidelines.
• Ensure audit readiness and develop collaborative relationships with investigational sites.
• Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis and problem-solving skills.
• Ensure data accuracy through SDR, SDV, and CRF review during monitoring activities.
• Document observations in reports and letters in a timely manner using approved business writing standards.
• Escalate observed deficiencies and issues to clinical management and follow through to resolution.
• Maintain regular contact with investigative sites to confirm protocol adherence and issue resolution.
• Conduct monitoring tasks in accordance with the approved monitoring plan.
• Participate in the investigator payment process and ensure shared responsibility on issues resolution with project team members.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• Ensure study systems are updated per agreed study conventions.
• Perform QC checks of reports generated from CTMS as required.
• Participate in investigator meetings as necessary and identify potential investigators in collaboration with the client company.
• Initiate clinical trial sites according to relevant procedures and ensure trial close out and retrieval of trial materials.
• Conduct on-site file reviews as per project specifications and assist in preparation of project publications/tools.

Requirements

• Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent.
• 2+ years of experience as a clinical research monitor.
• Valid driver's license where applicable.
• Effective clinical monitoring skills and understanding of medical/therapeutic area knowledge.
• Excellent understanding of ICH GCPs, applicable regulations, and procedural documents.
• Well-developed critical thinking skills and ability to manage Risk Based Monitoring concepts.
• Effective oral and written communication skills, especially with medical personnel.
• Strong attention to detail and effective organizational and time management skills.
• Ability to work independently or as part of a team and remain flexible in various scenarios.
• Proficient knowledge of Microsoft Office and ability to learn appropriate software.

Nice-to-haves

• Fluency in Spanish is prioritized for this role.

Benefits

• Support for career development and individual career goals.
• Resources for achieving work-life balance.
• Opportunities for professional growth and development.