Madrid, Community of Madrid, Spain · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Spain: Madrid and Barcelona ONLY Join Us as an Assistant Clinical Research Associate – Make an Impact at the Forefront of Innovation We hav…
Skills: Clinical Research, Site Management, ICH GCP, Remote Monitoring, Medical Terminology
City of Brisbane, Queensland, Australia · On-site
Work Schedule 12 hr shift/days Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed Job Description When you’re part of the team at Th…
Skills: cGMP Knowledge, Organizational Skills, Scheduling, Planning, Communication
Middleton, Wisconsin, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Position: Facilities Quality and Compliance Specialist Location: Middleton, Wisconsin Department: Facilities This is a fully onsite role ba…
Skills: GMP Compliance, Change Control, Risk Assessment, CMMS/CAFM, CAPA Development
Middleton, Wisconsin, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Fluctua…
Skills: Vendor Management, Facilities Management, GMP Compliance, Purchase Order Management, Space Planning
Ferentino, Lazio, Italy · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facia…
Skills: Sterile Manufacturing, cGMP Compliance, FDA Regulations, Aseptic Processing, Cleanroom Operations
Greenville, North Carolina, United States · On-site
Work Schedule 12 hr shift/nights Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail …
Skills: Batch Record Review, Deviation Management, CAPA Systems, cGMP Regulations, ISO Standards
Riyadh, Riyadh Region, Saudi Arabia · Hybrid
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
Middleton, Wisconsin, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Lou…
Skills: Building Automation System (BAS), Mechanical Controls, HVAC Troubleshooting, GMP Compliance, Preventive Maintenance
Ciudad de México, Mexico · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description We are the Clinical Trials Division (CTD): We Supply the Hope that Changes Lives CTD partners with pharmaceutical and biotech customers aro…
Skills: Financial Leadership, Strategic Business Partnering, Controllership, Financial Analysis, Monthly Close Process
Bogota, Capital District, RAP (Especial) Central, Colombia · 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: Sales Strategy, Customer Relationship Management, Negotiation, Territory Management, Strategic Account Planning
Rochester, New York, United States · On-site
$27/hr–$40/hr
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold, Laboratory Setting, Off…
Skills: Metrology, Product Development, Failure Analysis, Polymer Science, Measurement System Analysis
Vilnius, Vilnius County, Lithuania · On-site
$1k–$2k/mo
Work Schedule Flex Shifts 40 hrs/wk Environmental Conditions No contact lens allowed; prescriptive glasses will be provided, Will work with hazardous/toxic materials Job Description UAB „Thermo Fisher Scientific Baltics“…
Skills: Analytical Column Production, ERP Systems, English Language, Lithuanian Language, Computer Literacy
Madison, Wisconsin, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) J…
Skills: Mechanical Assembly, Electrical Assembly, Optical Assembly, Calibration, Soldering
Germantown, Maryland, United States · On-site
$15/hr–$23/hr
Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipmen…
Skills: Inventory Management, Cold Storage Operations, Microsoft Office Suite, Sample Management, Good Manufacturing Practices
Quezon City, Metro Manila, Philippines · Hybrid
Work Schedule Second Shift (Afternoons) 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 o…
Skills: Customer Support, Order Processing, CRM Systems, ERP Systems, Microsoft Office
Sacramento, California, United States · On-site
$80k–$112k/yr
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: Molecular Testing, NGS Testing, Sample Processing, Data Analysis, Laboratory Information Systems
Bengaluru, Karnataka, India · Hybrid
Work Schedule Second Shift (Afternoons) Environmental Conditions Office Job Description Join Us as a Senior Programmer Analyst Make an Impact at the Forefront of Innovation The Senior Programmer Analyst performs advanced…
Skills: Bioinformatics Programming, SAS, Clinical Trials, Data Management, Statistical Programming
Raleigh, North Carolina, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Director, Commercial Finance – Clinical Trials Division is a strategic finance leader responsible for driving commercial performance, p…
Skills: Commercial Finance, Pricing Strategy, Business Analytics, Revenue Optimization, Financial Modeling
Hillsboro, Oregon, United States · On-site
Work Schedule First Shift (Days) Environmental Conditions Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office Job Description As part of the Thermo Fi…
Skills: Electrical Troubleshooting, New Product Introduction, Failure Analysis, Root Cause Analysis, Technical Documentation
Center Valley, Pennsylvania, United States · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, our Finance teams are important to our business and functional teams to make educated, sound decisions that dr…
Skills: Monthly Closing, Journal Entries, Account Reconciliations, Internal Control Procedures, Division Consolidation
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Provide logistical and administrative support for clinical trial site preparedness and remote monitoring activities. Coordinate site management tasks, document collection, and system access in accordance with SOPs and regulatory guidelines.
Requires a Bachelor's degree in life sciences, nursing, or a related field with 0 to 2 years of relevant experience. Candidates must possess basic medical knowledge, proficiency in English, and a working understanding of ICH GCP regulations.
Join Us as an Assistant Clinical Research Associate – 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 remote activities on assigned projects in liaison with the CRA and study Clinical Lead. As an Assistant Clinical Research Associate, you'll provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. You may be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.
What You’ll Do:
• Completes study and site management activities as defined in task matrix, andas applicable and directed for study assigned.
• Completes and documents study-specific training.
• Orients and trains on any study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and verifies site information.
• Reviews patient facing materials and review translations, as directed.
• Supports site staff with the vendor related qualification process, where applicable.
• Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
• Provides support to follow-up on site staff training, as applicable.
• Coordinates and supports logistics for IM attendance, as directed.
• Supports maintenance of vendor trackers, as directed.
• Coordinates study/site supply management during pre-activation and subsequent course of the study.
• Supports Essential Document collection, review and updating in systems, as applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
• Supports ongoing remote review of centralized monitoring tools, as directed.
• Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
• Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
• Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
• May perform other assigned site management tasks, as directed by CRA and as per Task Matrix.
• May perform a specific role profile for FSP opportunities according to Client requests.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Education and Experience Requirements:
• Bachelor's degree in a life science discipline or related field or 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 0 to 2 years).
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:
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
• Effective oral and written communication skills
• Excellent interpersonal and customer service skills
• Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
• Proven flexibility and adaptability
• Ability to work in a team or independently, as required
• Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
• Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
• Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
• Excellent English language and grammar skills
Working Conditions and Environment:
• Work is performed most of the time in an office or home office environment.; occasional travel toclinics/hospitals may be required.
• Exposure to electrical office equipment.
• The Assistant CRA role does not involve regular travel, however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).
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
