Tianjin, Tianjin, China · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation We have successfully supported the top …
Skills: Clinical Monitoring, ICH-GCP, Risk-Based Monitoring, Root Cause Analysis, Site Management
Beijing, Beijing, China · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Summary of Essential Functions: Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional specia…
Skills: Clinical Trial Monitoring, Regulatory Submissions, ICH-GCP, Site Start-up, Contract Negotiation
Seoul, South Korea · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global …
Skills: Proteomics, Biomarker Discovery, Technical Troubleshooting, Customer Training, Distributor Management
Ciudad de México, Mexico · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Clinical Research Associate (Level I) – Make an Impact at the Forefront of Innovation We have successfully supported th…
Skills: Clinical Monitoring, ICH-GCP, Risk-Based Monitoring, Root Cause Analysis, Site Management
Nashik, Maharashtra, India · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Quality Assurance, Team Leadership, Regulatory Compliance, Deviation Management, CAPA
Budapest, Central Hungary, Hungary · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Project Management, People Management, Stakeholder Management, Process Improvement, Change Management
Beijing, Beijing, China · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Operations Strategy Consultant – Make an Impact at the Forefront of Innovation and Thermo Fisher China Growth strategy. At The…
Skills: Proposal Development, Clinical Project Management, Operational Strategy, Stakeholder Management, Budgeting
Milan, Lombardy, Italy · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable o…
Skills: Sales, Contract Renewals, Customer Relationship Management, Upselling, Outbound Sales
Poland · Remote Solely
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Business Analysis, Vendor Relationship Management, Process Improvement, Requirements Gathering, Lean Six Sigma
Taguig, Metro Manila, Philippines · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of our PPD clinical research team, you’ll have the opportunity to support groundbreaking studies that make a real difference in pat…
Skills: Customer Service, Technical Support, Ticket Triage, Adverse Event Identification, Product Complaint Handling
Vilnius, Vilnius County, Lithuania · On-site
$3k–$4k/mo
Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Descriptio…
Skills: LC-MS, Mass Spectrometry Data Interpretation, Organic Synthesis, Quality Control, Proteomics
Monza, Lombardy, Italy · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning…
Skills: Technology Transfer, Bioprocess Optimization, GMP Risk Analysis, Process Scale-up, Upstream Processing
Osterode, Thuringia, Germany · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Thermo Fisher Scientific Inc. ist der weltweit führende Partner für die Wissenschaft mit einem Umsatz von über 40 Mrd. USD und mehr als 120…
Skills: AI Programming, Data Processing, MS Excel, MS Word, Process Digitalization
Munich, Bavaria, Germany · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation The Clinical Trial Manager is accountable for achieving…
Skills: Clinical Trial Management, ICH GCP, Clinical Monitoring, Trial Master File Management, Budgeting and Forecasting
Merelbeke, Flanders, Belgium · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. J…
Skills: Installation, Troubleshooting, Preventive Maintenance, Validation Services, Remote Diagnostics
Munich, Bavaria, Germany · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 ph…
Skills: Clinical Trial Coordination, eTMF Management, ICH GCP, Project Coordination, Regulatory Documentation
Munich, Bavaria, Germany · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmace…
Skills: Regulatory Submissions, Local Regulatory Strategy, Site Activation, Clinical Trial Coordination, Documentation Quality
Loughborough, England, United Kingdom · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs…
Skills: People Leadership, Team Management, Quality Management Systems, Lean Manufacturing, Continuous Improvement
Rotherham, England, United Kingdom · Remote Solely
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bring…
Skills: Medical Writing, Regulatory Writing, Clinical Study Reports, Protocol Development, Investigator Brochures
Budapest, Central Hungary, Hungary · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description Business Job Title: Senior Credit & Collections Representative Career Band: 03 Career Track: Associate When you are part of…
Skills: Credit Management, Debt Collection, Rapport Building, Verbal Communication, Written Communication
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The CRA Level II is responsible for monitoring investigator sites to ensure protocol and regulatory compliance while managing site documentation. They conduct remote and on-site visits, perform data verification, and maintain collaborative relationships with investigative sites to guarantee subject safety and data reliability.
Requires a Bachelor's degree in life sciences, a Nursing certification, or equivalent qualification. Candidates must have approximately one year of experience as a clinical research monitor or completion of the PPD Drug Development Fellowship.
Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You’ll Do:
• Monitors investigator sites with a risk-based monitoring approach applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
• Participates in investigator meetings as necessary. Identifies potential
• investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
• Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
• Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Contributes to other project work and initiatives for process improvement, as required.
Education and Experience Requirements:
• Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
• Proven clinical monitoring skills
• Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
• Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
• Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
• Ability to manage Risk Based Monitoring concepts and processes
• Good oral and written communication skills, with the ability to communicate effectively with medical personnel
• Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues
• Good organizational and time management skills
• Effective interpersonal skills
• Attention to detail
• Ability to remain flexibile and adaptable in a wide range of scenarios
• Ability to work in a team or independently as required
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
Working Conditions and Environment:
• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
• Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
