Thermo Fisher Scientific

Sr CRA (Level I)

Thermo Fisher Scientific • $80K — $95K *
US-AnywhereRemote in Georgia, US
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences or Registered Nursing qualification
  • 2+ years of Clinical Research Monitor/CRA experience or relevant experience
  • Valid driver's license as required
  • Ability to consider equivalent education and experience combinations
  • Good written and spoken English proficiency.

Responsibilities

  • Perform remote and on-site monitoring activities using a risk-based approach.
  • Conduct Source Data Review and Source Data Verification to ensure data quality.
  • Assess investigational product accountability through inventory review.
  • Identify site deficiencies and implement corrective actions.
  • Maintain communication with sites for compliance and issue resolution.
  • Ensure trials comply with approved protocols and regulations.
  • Participate in investigator meetings and initiate clinical trial sites.

Benefits

  • Standard Monday to Friday schedule.
  • Opportunities for professional development in clinical monitoring.
  • Exposure to a variety of clinical trial environments and processes.
  • Collaborative work culture with cross-functional teams.
  • Travel opportunities to clinical sites, enhancing networking and experience.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

As a Senior Clinical Research Associate (CRA), Level I, you'll play an important role in the successful delivery of clinical trials, working closely with investigational sites, sponsors, and cross-functional project teams.

You'll manage and coordinate all aspects of clinical monitoring and site management, conducting both remote and on-site visits to ensure trials are performed in accordance with approved protocols, ICH-GCP, applicable regulations, and company and sponsor procedures. As a trusted partner to investigational sites, you'll help safeguard patient rights and well-being while ensuring the quality and reliability of clinical trial data.

What You'll Do
Clinical Monitoring & Site Management
  • Perform remote and on-site monitoring activities using a risk-based monitoring approach.
  • Conduct Source Data Review (SDR), Source Data Verification (SDV), and CRF review, as applicable, to ensure data quality and accuracy.
  • Assess investigational product accountability through inventory and records review.
  • Apply critical thinking, root-cause analysis, and problem-solving techniques to identify site process issues and implement appropriate corrective and preventive actions.
  • Identify, document, escalate, and follow through on site deficiencies and issues until resolution.
  • Maintain regular communication with investigational sites between monitoring visits to support protocol compliance, timely data entry, and issue resolution.
  • Conduct monitoring activities in accordance with approved monitoring plans.

Study Delivery & Compliance
  • Ensure clinical trials are conducted in accordance with approved protocols, ICH-GCP, applicable regulations, and relevant SOPs and procedures.
  • Ensure essential study documents are complete, accurate, and maintained according to regulatory requirements.
  • Conduct on-site file reviews according to project requirements and support ongoing audit and inspection readiness.
  • Initiate clinical trial sites and support site close-out activities, including the retrieval of study materials.
  • Participate in investigator meetings and support the identification and assessment of potential investigational sites.
  • Respond to company, sponsor, and applicable regulatory audit and inspection requirements.

Project Collaboration
  • Provide study status and progress updates to the Clinical Team Manager (CTM).
  • Maintain accurate and timely information in study systems, including the Clinical Trial Management System (CTMS).
  • Perform quality checks of CTMS-generated reports where required.
  • Facilitate effective communication between investigational sites, sponsors, and the wider project team.
  • Contribute to project tools, communications, and publications and share ideas and best practices with colleagues.
  • Support additional study activities as assigned, which may include trip report reviews, newsletters, or leading CRA team calls.
  • Participate in investigator payment processes as required.
  • Contribute to project and cross-functional process improvement initiatives.
  • Complete required administrative activities, including expense reports and timesheets, accurately and on time.

What We're Looking For

Minimum Qualifications
  • Bachelor's degree in a life sciences-related field, Registered Nursing qualification, or equivalent relevant academic/vocational qualification.
  • At least 2+ years of experience as a Clinical Research Monitor / CRA, or comparable relevant experience.
  • Valid driver's license, where applicable.
  • Equivalent combinations of education, training, and directly related experience may also be considered.

Preferred Skills & Experience
  • Strong clinical monitoring and site management skills.
  • Excellent understanding and practical application of ICH-GCP, applicable regulations, and clinical research procedures.
  • Good knowledge of medical terminology and relevant therapeutic areas.
  • Experience applying Risk-Based Monitoring (RBM) principles and processes.
  • Strong critical thinking, root-cause analysis, and problem-solving capabilities.
  • Excellent attention to detail with strong organizational and time-management skills.
  • Effective written and verbal communication skills, including the ability to communicate confidently with medical professionals and investigational site staff.
  • Strong interpersonal skills and a collaborative, customer-focused approach.
  • Ability to adapt to changing priorities and work effectively both independently and as part of a global team.
  • Proficiency in Microsoft Office and the ability to quickly learn clinical trial systems and software.
  • Good written and spoken English.
  • Strong presentation skills.

Working Environment & Travel

This is a field-based clinical monitoring role that requires regular travel to investigational sites.
  • Frequent travel is required, typically 60-80%, depending on study and business needs.
  • Regular driving to clinical trial sites may be required.
  • Travel may include extended and overnight stays.
  • Work may be performed in home-office, office, laboratory, and clinical environments.
  • The role may involve exposure to biological materials in clinical environments, with appropriate personal protective equipment provided or required.
  • You will be expected to comply with applicable sponsor, client, and investigational site requirements.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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