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

Thermo Fisher Scientific - Orlando, FL

Full-time - Mid Level

Hybrid - Orlando, FL

Computer and Electronic Product Manufacturing

About the position

The position is for an experienced Clinical Research Associate (CRA) at Thermo Fisher Scientific, focusing on onsite and traveling responsibilities. The role involves monitoring clinical trials, ensuring compliance with protocols and regulations, and maintaining high-quality standards in clinical research. Candidates fluent in Spanish and with experience in oncology, cell or gene therapy, ophthalmology, or CNS are prioritized. The CRA will work closely with investigational sites and contribute to the success of clinical trials across various therapeutic areas.

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 in a timely manner.
• 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 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 and perform QC checks of reports as required.
• Identify potential investigators in collaboration with the client company and initiate clinical trial sites according to relevant procedures.
• Ensure trial close out and retrieval of trial materials, ensuring essential documents are complete and compliant with regulations.
• Contribute to project team by assisting in preparation of project publications/tools and sharing ideas with team members.

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 or equivalent experience.
• 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, with the ability to communicate with medical personnel.
• Strong attention to detail and effective organizational and time management skills.

Nice-to-haves

• Fluency in Spanish is prioritized for this role.
• Experience in oncology, cell or gene therapy, ophthalmology, or CNS.

Benefits

• Support for career development and individual career goals.
• Resources needed to achieve work-life balance.