Principal CRA
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Senior CRA monitoring clinical trials for Thermo Fisher Scientific's global research programs. Ensuring site compliance, data quality, audit readiness, and patient safety.
Responsibilities:
- Manage and coordinate all aspects of clinical monitoring and site management
- Perform remote and on-site monitoring activities using a risk-based monitoring approach
- Conduct Source Data Review, Source Data Verification, and CRF review as applicable
- Assess investigational product accountability through inventory and records review
- Identify site process issues and implement corrective and preventive actions
- Identify, document, escalate, and follow through on site deficiencies and issues until resolution
- Maintain communication with investigational sites between monitoring visits
- Ensure trials follow approved protocols, ICH-GCP, applicable regulations, SOPs, and procedures
- Ensure essential study documents are complete, accurate, and maintained according to regulatory requirements
- Conduct on-site file reviews and support audit and inspection readiness
- Initiate clinical trial sites and support site close-out activities
- Participate in investigator meetings and support identification and assessment of potential investigational sites
- Respond to company, sponsor, and regulatory audit and inspection requirements
- Provide study status and progress updates to the Clinical Team Manager
- Maintain accurate and timely information in study systems, including CTMS
- Perform quality checks of CTMS-generated reports
- Facilitate communication between sites, sponsors, and project teams
- Contribute to project tools, communications, publications, process improvements, and best-practice sharing
- Support additional study activities such as trip report reviews, newsletters, or leading CRA team calls
- Participate in investigator payment processes
- Complete expense reports and timesheets accurately and on time
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
- 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
- Ability to travel frequently, typically 60–80%
- Ability to drive regularly to clinical trial sites
- Ability to undertake extended and overnight stays when required
- Compliance with applicable sponsor, client, and investigational site requirements
Benefits:
- The opportunity to work on innovative and diverse global clinical research programs
- Exposure to a broad range of sponsors, therapeutic areas, and clinical trial environments
- A collaborative and inclusive culture where your expertise and ideas are valued
- Continuous learning, professional development, and opportunities for career progression
- Competitive compensation and benefits
- Appropriate personal protective equipment provided or required for exposure to biological materials
Similar Jobs
Principal Quantitative Researcher, Federal Health Program Implementation and Evaluation
Principal quantitative researcher leading CMS/CMMI alternative payment model implementation and evaluation. Commence delivers data-driven healthcare solutions for federal agencies.
Deputy Principal – Ethical Digital Fluency, Safeguarding
Deputy Principal safeguarding learners at New Zealand's first online charter school. Leading AI guidance, digital citizenship, child protection and Year 9 pastoral care.
Deputy Principal – High Standards Teaching
Deputy Principal developing teaching practice at New Zealand's first online charter school. Leading coaching, professional growth, PLD and online learning standards.
Deputy Principal – High Standards Learner Experience
Deputy Principal leading attendance, learning support and student services at New Zealand’s first online charter school. Overseeing engagement systems, pastoral care and Board reporting.
Principal, Spend Management Lead
Spend Management Principal leading complex client engagements for Vizient, a healthcare performance improvement company. Driving financial outcomes, governance, supplier relationships, and executive stakeholder alignment.
Principal Client Advisor – Tech
Principal Client Advisor advising enterprise clients and expanding accounts for Karat, the world's largest interviewing company. Driving hiring transformation through analytics, strategic consultation, and executive relationships.
Principal Researcher – CMMI Evaluations
Principal Researcher leading CMS/CMMI payment-model evaluations for AIR, a behavioral and social science research nonprofit. Directing research, federal business development, proposals, and evaluation teams.
Principal Resource Geologist
Principal Resource Geologist leading geological models, resource estimates, and compliant technical disclosures for Wood’s global mining consultancy. Acting as Qualified Person across major mining projects and commodities.
Principal Enterprise Renewal Representative – Enterprise Accounts, French Speaker
Enterprise renewal representative driving Autodesk’s strategic software agreement renewals in France. Negotiating enterprise terms, managing renewal risk, and identifying expansion opportunities.
Principal Investigator, Terrestrial Archaeology
Principal Investigator leading terrestrial archaeology projects for SEARCH, a global cultural heritage services firm. Managing research, fieldwork, technical reports, staff, clients, budgets, and regulatory compliance.
Principal – Strategic Transformation
Principal driving AI-enabled strategic transformation across Blackboard’s EdTech and SaaS operations. Managing portfolio governance, analysis, prioritization, and internal automation.
Turnaround K-12 School Principal
Principal leading ACCEL Schools’ virtual K-12 academy in Florida. Driving academic outcomes, instructional quality, teacher performance, and school operations.
Senior Principal, Contracts
Senior Contracts Principal managing complex government contracts and proposals for SAIC, a defense and technology mission integrator. Advising programs, negotiating agreements, and mitigating contractual and financial risk.
Senior Principal Clinical Leader – RN, BH
Senior Principal Clinical Leader overseeing Aetna’s Michigan and Illinois integrated-plan care management. Driving compliant operations, quality improvement, vendor relationships, and clinical workforce performance.
Regional Senior Market Leader, Principal
Private Wealth Senior Market Leader raising assets and building advisor relationships for Blue Owl, an alternative asset manager. Covering Massachusetts and the Northeast market across private-market investment products.
Regional Senior Market Leader – Principal
Private Wealth Senior Market Leader raising capital and managing advisor relationships for Blue Owl’s alternative-investment platform. Serving Connecticut and the Northeast market through sales campaigns, client meetings, and territory growth.
Principal Researcher, Healthcare Transformation
Principal Researcher leading rigorous healthcare transformation research at nonprofit AIR. Guiding multidisciplinary studies, funding strategy, stakeholder partnerships, and evidence-based policy insights.
Senior Contracts Principal
Senior Contracts Principal supporting complex Army and Navy defense proposals for SAIC. Preparing cost and FFP proposals, contractual artifacts, and OCI mitigation plans.
Principal Researcher, Youth Development
Principal Researcher leading AIR’s youth development research, evaluation, technical assistance, and business development. Managing complex projects, proposals, teams, budgets, and client relationships.
Principal CRA
Principal CRA monitoring clinical trials for Thermo Fisher Scientific's pharmaceutical and biotech clients. Ensuring protocol compliance, site performance, data accuracy, and audit readiness through remote and on-site visits.