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- Tasks: Coordinate clinical monitoring and site management for impactful health research.
- Company: Join Thermo Fisher Scientific, a leader in making the world healthier and safer.
- Benefits: Enjoy flexible work options, career growth opportunities, and a supportive team culture.
- Why this job: Make a real difference in global health while developing your skills in a dynamic environment.
- Qualifications: Bachelor's in life sciences or nursing; 2+ years of clinical research experience required.
- Other info: Be part of a diverse team of over 100,000 colleagues committed to innovation and integrity.
The predicted salary is between 36000 - 60000 £ per year.
Senior / Clinical Research Associate – UK (several locations)
Join to apply for the Senior / Clinical Research Associate – UK (several locations) role at Thermo Fisher Scientific
Senior / Clinical Research Associate – UK (several locations)
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Join to apply for the Senior / Clinical Research Associate – UK (several locations) role at Thermo Fisher Scientific
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Senior/CRA – United Kingdom
PPD, part of Thermo Fisher Scientific are currently hiring for experienced Clinical Research Associates across the UK
Work Schedule
Other
Environmental Conditions
Office
Senior/CRA – United Kingdom
PPD, part of Thermo Fisher Scientific are currently hiring for experienced Clinical Research Associates across the UK
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our clinical department defines, develops and delivers clinical programmes. Our global Clinical Operations colleagues within our PPD clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient clinical studies.
PPD Clinical Research Services are currently hiring for experienced CRAs to join our team in the UK across a range of locations
The CRA:
- Performs and coordinates all aspects of the clinical monitoring and site management process.
- Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation..
- Acts as a site processes specialist, ensuring 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.
- Ensures audit readiness.
- Develops collaborative relationships with investigational sites.
- Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
A day in the Life:
- 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.
- Brings up 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
- 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, CTMS).
- Performs QC check of reports generated from CTMS system where required.
- 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. Ensures 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.
- Gives to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
- 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.
- Gives to other project work and initiatives for process improvement, as required.
Education And Experience
- Bachelor\’s degree in a life sciences 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 2+ years as a clinical research monitor).
- Valid driver\’s license
- Full Right to work in the UK
- Fluency in English language
Knowledge, Skills, Abilities
- Effective clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical attitude, in-depth investigation for appropriate root cause analysis and decision-making
- Ability to handles Risk Based Monitoring concepts and processes
- Effective 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
- Effective social 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
- Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
- Good presentation skills
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Seniority level
-
Seniority level
Not Applicable
Employment type
-
Employment type
Full-time
Job function
-
Job function
Research and Science
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Industries
Pharmaceutical Manufacturing and Biotechnology Research
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Senior / Clinical Research Associate - UK (several locations) employer: Thermo Fisher Scientific
Contact Detail:
Thermo Fisher Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior / Clinical Research Associate - UK (several locations)
✨Tip Number 1
Familiarise yourself with the latest ICH-GCP guidelines and regulations. Being well-versed in these standards will not only boost your confidence during interviews but also demonstrate your commitment to maintaining high-quality clinical research practices.
✨Tip Number 2
Network with current or former Clinical Research Associates at Thermo Fisher Scientific. Engaging with them can provide you with insider knowledge about the company culture and expectations, which can be invaluable during the interview process.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled challenges in previous clinical trials. Highlighting your problem-solving skills and ability to adapt to changing situations will resonate well with the hiring team.
✨Tip Number 4
Stay updated on the latest trends and technologies in clinical research. Showing that you're proactive about learning and adapting to new methodologies can set you apart from other candidates.
We think you need these skills to ace Senior / Clinical Research Associate - UK (several locations)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical research. Focus on your monitoring skills, knowledge of ICH-GCP guidelines, and any specific therapeutic areas you've worked in.
Craft a Strong Cover Letter: In your cover letter, express your passion for clinical research and how your background aligns with the mission of Thermo Fisher Scientific. Mention specific experiences that demonstrate your problem-solving skills and attention to detail.
Highlight Relevant Skills: Emphasise your effective communication skills, critical thinking abilities, and experience with risk-based monitoring. These are key attributes for a Clinical Research Associate role.
Proofread Your Application: Before submitting, carefully proofread your application materials. Look for any grammatical errors or typos, as these can detract from your professionalism and attention to detail.
How to prepare for a job interview at Thermo Fisher Scientific
✨Know Your Clinical Research Basics
Make sure you have a solid understanding of clinical research principles, including ICH-GCP guidelines and regulatory compliance. Brush up on your knowledge of medical terminology and therapeutic areas relevant to the role.
✨Demonstrate Problem-Solving Skills
Be prepared to discuss specific examples where you've used critical thinking and problem-solving skills in previous roles. Highlight how you approached challenges in clinical monitoring and site management.
✨Showcase Your Communication Skills
Effective communication is key in this role. Practice articulating your thoughts clearly and concisely, both verbally and in writing. Be ready to explain how you've maintained strong relationships with investigative sites and team members.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your ability to handle real-life situations in clinical trials. Think about past experiences where you had to ensure compliance or resolve issues, and be ready to share those stories.
