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

Thermo Fisher Scientific - Cleveland, OH

Full-time - Mid Level

Hybrid - Cleveland, OH

Computer and Electronic Product Manufacturing

About the position

The position is for an experienced Clinical Research Associate (CRA) at Thermo Fisher Scientific, focusing on clinical monitoring and site management for clinical trials. The role requires candidates to have a strong background in oncology, cell or gene therapy, ophthalmology, or CNS, and fluency in Spanish is prioritized. The CRA will be responsible for ensuring compliance with protocols and regulations, conducting site visits, and maintaining quality and accuracy in clinical trials.

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 to ensure trials are conducted according to approved protocols and regulations.
• Ensure audit readiness and develop collaborative relationships with investigational sites.
• Monitor investigator sites using a risk-based monitoring approach and apply root cause analysis to identify site process failures.
• Ensure data accuracy through various review processes and document observations in reports.
• 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.
• Participate in the investigator payment process and ensure shared responsibility on issues resolution.
• Provide trial status tracking and progress update reports to the Clinical Team Manager (CTM).
• Ensure study systems are updated per agreed conventions and perform QC checks of reports.
• Identify potential investigators and initiate clinical trial sites according to relevant procedures.
• Ensure trial close out and retrieval of trial materials, maintaining essential documents as per regulations.
• Contribute to project publications/tools and assist in preparation as needed.

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 terminology.
• Excellent understanding of ICH GCPs and applicable regulations.
• 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 skills.
• Ability to work independently and in a team environment.
• Proficient knowledge of Microsoft Office and ability to learn relevant software.

Nice-to-haves

• Fluency in Spanish is prioritized for this role.

Benefits

• Support for career development and individual goals.
• Resources for achieving work-life balance.
• Opportunities to work on impactful projects that improve health outcomes.