Clinical Research Associate - FSP
About the job
- A bachelor's degree in a life sciences-related field, Registered Nursing certification, or an equivalent relevant formal academic or vocational qualification.
- Previous experience comparable to at least 2 years as a clinical research monitor.
- Effective clinical monitoring skills.
- Demonstrated understanding of medical or therapeutic area knowledge and medical terminology.
- Thorough understanding and demonstrated application of ICH-GCPs, applicable regulations, and procedural documents.
- Well-developed critical thinking skills, including a critical mindset, in-depth investigation for appropriate root cause analysis, and problem solving.
- Ability to manage risk-based monitoring concepts and processes.
- Ability to communicate effectively with medical personnel through oral and written communication.
- Ability to maintain customer focus using good listening skills, attention to detail, and the ability to perceive customers’ underlying issues.
- Effective interpersonal skills.
- Strong attention to detail.
- Effective organizational and time-management skills.
- Ability to remain flexible and adaptable in a wide range of scenarios.
- Ability to work in a team or independently as required.
- Proficient knowledge of Microsoft Office and ability to learn appropriate software.
- Good English language and grammar skills.
- Good presentation skills.
- Monitor investigator sites using a risk-based monitoring approach; apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective or preventive actions that bring sites into compliance and decrease risks.
- Ensure data accuracy through source data review, source data verification, and case report form review, as applicable, through on-site and remote monitoring activities.
- Assess investigational product through physical inventory and records review.
- Document observations in reports and letters in a timely manner using approved business-writing standards.
- Expeditiously escalate observed deficiencies and issues to clinical management and follow issues through to resolution.
- Maintain regular contact between monitoring visits as needed to confirm protocol compliance, resolution of previously identified issues, and timely data recording.
- Conduct supervising tasks in accordance with the approved monitoring plan.
- Participate in the investigator payment process.
- Share responsibility with other project team members for resolving issues and findings; investigate and follow up on findings as applicable.
- Provide trial status tracking and progress-update reports to the Clinical Team Manager as required.
- Update study systems, such as the Clinical Trial Management System, according to agreed study conventions and quality-check system-generated reports where required.
- Participate in investigator meetings as needed.
- Identify potential investigators in collaboration with the client company to ensure qualified investigative sites are acceptable.
- Initiate clinical trial sites according to relevant procedures to ensure compliance with the protocol, regulatory requirements, and ICH GCP obligations, making recommendations where warranted.
- Ensure trial closeout and retrieval of trial materials.
- Ensure required essential documents are complete and in place according to ICH-GCP and applicable regulations.
- Conduct on-site file reviews according to project specifications.
- Assist with preparation of project publications and tools, and share ideas and suggestions with team members.
- Perform additional study tasks as assigned by the Clinical Trial Manager, such as trip report review, newsletter creation, and leading CRA team calls.
- Facilitate effective communication between investigative sites, the client company, and the PPD project team through written, oral, or electronic contacts.
- Respond to company, client, and applicable regulatory requirements, audits, and inspections.
- Complete administrative tasks such as expense reports and timesheets in a timely manner.
- Contribute to other project work and process-improvement initiatives as required.
About the company
Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.
Company Size
10,001+
Company Stage
IPO
Headquarters
Waltham, Massachusetts
Founded
1956
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Simplify's Take
What believers are saying
- Drugmaker demand is firming: revenue rose 10% to $11.99 billion in the June 2026 quarter, 5% excluding deals and currency.
- Profits are outpacing sales, which supports stock grants: adjusted earnings per share rose 13% in the June 2026 quarter.
- Career paths span many businesses: Thermo Fisher runs four segments, from diagnostics to contract drug development.
What critics are saying
- Factory jobs are shrinking: Thermo Fisher announced in January 2026 it will close its Asheville plant, cutting 421 jobs.
- Whole units get sold: microbiology, with $645 million in 2025 sales, went to buyout firm Astorg in August 2026.
- Cuts reach California too: Thermo Fisher filed in January 2026 to lay off 173 Carlsbad workers by March.
What makes Thermo Fisher Scientific unique
- Many familiar lab brands sit under one roof: Thermo Fisher owns Thermo Scientific, Applied Biosystems, Invitrogen and Fisher Scientific.
- Thermo Fisher reaches labs through its own sales force of about 14,000 people, per its 2025 annual filing.
- Its trial-data unit Clario has supported about 70% of FDA and EMA novel drug approvals over the past decade.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Unlimited Paid Time Off
Paid Vacation
Paid Sick Leave
Paid Holidays
Hybrid Work Options
401(k) Retirement Plan
401(k) Company Match
Employee Stock Purchase Plan
Fertility Treatment Support
Family Planning Benefits
Professional Development Budget
Conference Attendance Budget
Wellness Program
Mental Health Support
Gym Membership
Phone/Internet Stipend
Home Office Stipend
Company News
Thermo Fisher Scientific is showcasing expanded drug development and manufacturing capabilities at CPHI Milan 2026, running 6-8 October. The company is introducing OSD Express for oral solid dose development and expanding small molecule capabilities through collaboration with AustinPx, which provides access to KinetiSol Technology for improving drug bioavailability. The firm is investing in tableting, laboratory and packaging facilities across France, Canada and North America. For sterile products, new Steriles Express Solutions aim to deliver Phase I or II clinical trial material in 20 weeks. Thermo Fisher is also expanding bioprocessing capacity and clinical trial supply infrastructure, including a 52,000-square-foot facility in New York. The company is deploying generative AI to reduce master informed consent form drafting time by 50%. Thermo Fisher generates over $45 billion in annual revenue.
Thermo Fisher Scientific showcases new solutions and expanded capabilities to accelerate Drug Development at CPHI Milan 2026. Key Takeaway: Thermo Fisher Scientific is set to showcase its expanded drug development and manufacturing capabilities at CPHI Milan 2026. The company aims to assist pharmaceutical and biotechnology firms in navigating complex commercialization processes. Among its new offerings is OSD Express, designed to enhance predictability in drug development. Market sentiment analysis. Positive factors. * Thermo Fisher Scientific is expanding its drug development capabilities. * New solutions aim to help companies navigate commercialization paths. * Showcasing innovations at a major industry event enhances visibility. New development solutions, expanded global capacity, and advanced digital technologies help pharma and biotech companies reduce complexity and scale toward commercialization Key facts. - New solutions for drug product development:New OSD Express and Steriles Express Solutions provide defined development approaches designed to increase predictability and help programs advance more efficiently, while Accelerator(TM) Drug Development connects capabilities across development to reduce handoffs and maintain continuity. - Expanded capabilities and capacity:Investments across oral solid dose, sterile drug product, biologics, and clinical supply are expanding development and manufacturing capabilities globally, including new small molecule technologies through Thermo Fisher's collaboration with AustinPx. - Technology delivering measurable impact:AI, data, and digital technologies are being applied across clinical development, including generative AI applications that reduced master informed consent form draft time by 50% and, in some studies, reduced CRA site enrollment and activation activities by 15-30%. MILAN-(BUSINESS WIRE)-Thermo Fisher Scientific, the world leader in serving science, is expanding its drug development, manufacturing, and clinical capabilities to help pharmaceutical and biotechnology companies navigate increasingly complex paths to commercialization, reduce friction, and maintain momentum. The company will showcase these new and expanded capabilities at CPHI Milan 2026, Oct. 6-8. Among the new offerings isOSD Express, a defined solution designed to increase predictability and advance oral solid dose development more efficiently. The offering reflects the broader approach ofAccelerator(TM) Drug Development, which connects scientific expertise and capabilities across drug development, clinical trials, endpoint solutions, clinical supply, and laboratory services to reduce handoffs and help customers maintain continuity as programs advance. Additionally, Thermo Fisher is expanding small molecule capabilities through its collaboration withAustinPx, giving customers access to KinetiSol(TM) Technology, a solvent-free technology designed to improve the bioavailability of poorly soluble drugs and support development and scale-up through commercial manufacturing. Targeted investments in tableting, laboratory, and packaging capabilities are also expanding oral solid dose development and commercial manufacturing, including new Gerteis technology for advanced dry granulation and improved tablet manufacturing efficiency in Bourgoin, France, and Whitby, Canada, and serialized packaging capabilities in Cincinnati and Toronto. For sterile drug product programs,Steriles Express Solutionsprovide a defined approach for early development and late-stage technology transfer. Steriles Express Early Development is designed to provide Phase I or II clinical trial material in as little as 20 weeks, while Steriles Express Tech Transfer can provide a Phase III GMP batch in as little as 26 weeks.* Supporting these pathways are continued investments in sterile drug product capacity, including new and expanded lines in Plainville, Massachusetts; Monza, Italy; and Ferentino, Italy, for development and commercial manufacturing of vials and prefilled syringes. Thermo Fisher is also expanding fill-finish and drug-device capabilities in Ridgefield, New Jersey, including through its previously announcedcollaboration with SHL Medical. "Drug development increasingly depends on decisions and capabilities that span traditional boundaries, from development and manufacturing to clinical supply and clinical execution," said Mike Shafer, Executive Vice President and President, Biopharma Services, Thermo Fisher Scientific. "We're investing not only in capacity, but in how those capabilities connect. That gives our customers greater continuity as they navigate critical transitions, scale their programs, and prepare for commercialization." Strengthening capabilities across the development pathway. Beyond drug product, Thermo Fisher continues to invest in capabilities across biologics development, manufacturing, and clinical supply. New bioprocessing equipment in Plainville will expand U.S.-based cGMP monoclonal antibody manufacturing capacity, while the recently openedU.S. Bioprocess Design Centerhelps customers translate process innovations into scalable solutions for biologics development and manufacturing. Thermo Fisher has also expanded its Gibco(TM) cell culture media portfolio withCHO-K1 Catalog Panel Media and Feed, a cGMP-ready portfolio designed to support cell growth and protein production. In clinical trial supply, a 52,000-square-foot expansion in Bohemia, New York, will increase clinical label manufacturing capacity, while a new facility in Heiwajima, Tokyo, is expected to approximately double Japan's storage, distribution and secondary packaging capacity, ranging from controlled ambient to ultra-low temperature. Across the global clinical supply network, Thermo Fisher is also making significant investments in technologies supporting drug-device combination product assembly, labeling and packaging. These scalable technologies enable fit-for-phase automation, supporting programs from early clinical development through commercialization as volume and complexity increase. Applying digital technologies and data to improve development execution. Thermo Fisher is applying AI, data, and digital technologies to improve execution and support more informed decisions across clinical development. Within the PPD(TM) clinical research business, generative AI is being used to accelerate clinical development activities, including a50% aggregate reductionin master informed consent form draft time. Thermo Fisher is also expanding evidence-generation capabilities through thePPD(TM) CorEvitas(TM) Vitiligo Registry, designed to generate longitudinal real-world evidence on treatment effectiveness, disease burden, and patient outcomes. In digital clinical solutions,Clario's eCOA Swiftcaptures patient-reported data in early-stage oncology trials to help sponsors better understand tolerability and patient impact as programs advance. Thermo Fisher experts share insights at CPHI Milan. These shifts in how drug development is executed, from the role of strategic partnerships to the practical application of AI, will also be explored by Thermo Fisher experts at CPHI Milan: CDMO Consolidation: Strategic Partnerships or Dangerous Dependencies?- Hannah Spaepen, Senior Director, CMC Portfolio Management, Pharma Services, will participate as a panelist Tuesday, Oct. 6, from 11:35 a.m. - 12:20 p.m. CET. Putting AI to work in drug development: Practical applications that deliver measurable value- Anil Kane, Global Head of Technical and Scientific Affairs, Pharma Services, will present Wednesday, Oct. 7, from 1:45 - 2:10 p.m. CET. To learn more about these and other developments, visit Thermo Fisher Scientific atbooth 6A2, where specialists in drug development, manufacturing, and clinical services will be available throughout the conference to discuss customer needs and challenges. * Actual Steriles Express timelines may vary based on defined program parameters and scope. About Thermo Fisher Scientific. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $45 billion. Its Mission is to enable its customers to make the world healthier, cleaner and safer. Whether its 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, BiopharmaWatch is here to support them. Its global team delivers an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its 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. Frequently asked questions. What is Thermo Fisher showcasing at CPHI Milan 2026? Thermo Fisher is showcasing its expanded drug development and manufacturing capabilities. What is OSD Express? OSD Express is a new solution designed to increase predictability in drug development. When is CPHI Milan 2026 taking place? CPHI Milan 2026 will be held from October 6 to 8. Who does Thermo Fisher aim to assist? Thermo Fisher aims to assist pharmaceutical and biotechnology companies.
Evosep has entered a reseller agreement with Thermo Fisher Scientific for its Evosep Eno separation platform. Through the partnership, Thermo Fisher Scientific will offer the platform as part of its mass spectrometry solutions portfolio, combining its global reach with Evosep's separation technology. The Evosep Eno platform addresses the need for standardised proteomics in research, drug discovery, and clinical applications. It delivers robustness, ease of use, and throughput whilst minimising operational complexity. Customers will be able to purchase Evosep Eno directly through Thermo Fisher Scientific. The platform enables standardised separations across laboratories, instruments, and operators, supporting reproducible results for large-scale studies. The agreement supports applications including population studies, biomarker discovery, drug development, and clinical proteomics initiatives.
AI accelerator cards reshape DNA sequencing workflows. The global market for AI DNA sequencer base-calling accelerator cards is expanding as genomics workflows require faster, more accurate nucleotide identification. These specialized compute modules offload signal processing and deep-learning inference from host CPUs, reducing data-transfer bottlenecks and enabling on-instrument analytics that once depended on large data-center environments. Growth is tied to rising sequencing demand, with sequencing expenditures projected to surpass US$ 30 billion annually. Long-read and single-cell applications are increasing the need for flexible AI-optimized compute, while clinical diagnostics, research and development, and personalized medicine are key application areas. On-premise integration, cloud-connected systems, and hybrid edge deployments are shaping adoption models. NVIDIA, Intel, Illumina, and Thermo Fisher Scientific lead the competitive field through GPU, ASIC, FPGA, and platform-specific approaches. Illumina has introduced the NovaBase AI card, while Thermo Fisher Scientific offers the Ion Torrent Accelerate Card. AMD, Xilinx, Hewlett Packard Enterprise, Cisco, Qualcomm, IBM, Pacific Biosciences, Oxford Nanopore Technologies, Roche Sequencing Solutions, BGI Genomics, and QIAGEN are pursuing specialized roles across the ecosystem. Europe is positioned as a highly advanced market due to strong research networks, privacy regulation, and sustainability priorities. North America benefits from federal research funding and biotech activity, while Asia-Pacific shows strong potential through expanding genomics infrastructure in China, Japan, South Korea, and India.
Thermo Fisher Scientific inc. launches Gibco? CHO-K1 Catalog Panel media and feed. Published on 09/23/2026 at 11:43 am EDT S&P Capital IQ Thermo Fisher Scientific announced the Gibco? CHO-K1 Catalog Panel, a cGMP-ready portfolio of basal and feed media designed to support strong cell growth and protein production across CHO-K1 cell lines. Available in liquid and dry powder media (DPM) formats, the panel can offer flexible options for process development, scale-up, and manufacturing. The panel consists of multiple basal media and feed combinations designed for a broad range of CHO-K1 cell lines, helping development teams rapidly identify medium and feed combinations that support higher performance. The chemically defined (CD), animal origin-free (AOF) formulations are cGMP-ready to support regulatory considerations. The Gibco CHO-K1 Catalog Panel helps upstream process development teams identify high-performing media and feed combinations. In a 14-day fed-batch study using a CHO-K1 GS cell line, select panel combinations demonstrated: · Up to 73% higher titer compared with the benchmark catalog media and feeds tested · Up to 202% higher peak viable cell density compared with the benchmark products tested · Strong product quality performance across tested conditions A cGMP-ready portfolio of basal and feed media for CHO-K1 cell culture and protein production. Biologics and biosimilars developers using CHO-K1 cell lines. It helps provide multiple ready-to-use media and feed options for evaluating and optimizing diverse CHO-K1 cell culture workflows. The panel combines demonstrated productivity and product quality performance with CD, AOF, cGMP-ready formulations and scalable liquid and DPM formats to support CHO-K1 process development through manufacturing. (C) S&P Capital IQ - Business Wire - 2026