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

Thermo Fisher Scientific - Nashville, TN

Full-time - Mid Level

Hybrid - Nashville, TN

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 to ensure trials are conducted in accordance with 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 generated from CTMS.
• Participate in investigator meetings 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 and contribute to project publications/tools as needed.
• Facilitate effective communication between investigative sites, the client company, and the PPD project team.
• Respond to company, client, and regulatory requirements/audits/inspections and maintain administrative tasks.

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.
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
• 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 effectively 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.
• Good computer skills, including proficiency in Microsoft Office and ability to learn appropriate software.
• Good presentation skills.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid time off
• Professional development opportunities
• Flexible scheduling options