Sr CRA (Level I)
About The Position
Join Us as a Senior Clinical Research Associate – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. Over the past five years, we have supported the world's top 50 pharmaceutical companies and more than 750 biotechnology organizations, contributing to over 2,700 clinical trials across 100+ countries. 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.
Requirements
- 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.
Nice To Haves
- 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.
Responsibilities
- 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.
- 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.
- 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.
Benefits
- Competitive compensation and benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
