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- Tasks: Lead clinical trials for a groundbreaking heart treatment device, ensuring quality and compliance.
- Company: Join a pioneering company revolutionizing heart attack treatment with innovative medical technology.
- Benefits: Enjoy competitive pay, flexible work arrangements, and opportunities for professional growth.
- Why this job: Be part of a mission-driven team making a real impact on patient outcomes in cardiology.
- Qualifications: Bachelor's in life sciences; experience in clinical research or medical devices preferred.
- Other info: Opportunity to work across Europe and collaborate with top professionals in the field.
The predicted salary is between 48000 - 72000 £ per year.
In recent decades treatment of heart attacks by minimally invasive percutaneous coronary intervention (PCI) has significantly improved the outcomes for patients. However, successful re-opening of the narrow or blocked coronary arteries does not always restore blood flow to the entire heart muscle.
Our client is developing a first in class medical device that will both diagnose MVO in real-time during PCI and serve as a treatment platform in the cath lab.
As they roll out their clinical trial across Europe, we are hiring a Senior Clinical Research Associate will help drive greenfield clinical activity for our clients novel technology, overseeing and managing clinica ltrials, and taking on advanced proctroing responsibiltites.
Responsibilities:
Proctoring and Case Support Duties
- Train assigned study staff on the correct use of the study device.
- Supervise/support the setup of the required site workflow to ensure study images and measurements are collected and of consistent quality.
- Maintain detailed proctoring records and documentation.
- Assist during live cases by supporting site staff
- In agreement with CPM, release clinical sites to independent use of the study device.
- Join occasional clinical cases to support safe and effective use of the study device.
- Clinical Trial Support.
- Manage clinical trial activities in alignment with the clinical project manager (CPM), from study initiation to close-out.
- Train and educate site staff on study CIP, the correct use of the study EDC software, the electronic Investigator Site File (eISF), and regulatory requirements.
- Conduct site qualification, initiation, monitoring, and close-out visits to ensure CIP adherence and data integrity.
- Collaborate with investigators and study site staff to resolve issues and ensure timely and accurate data collection.
- Work in close collaboration with CRO who manages the overall clinical study.
Regulatory Requirements Support
- Assist in the preparation IRB submissions and documents, as needed.
- Assist in internal and external audits and inspections at study sites, ensuring compliance with regulatory requirements.
- Data Management.
- Ensure accurate and timely data collection in eCRF, monitoring, and validation according to the CIP and associated documents.
- Collaborate with Data Management team to resolve data discrepancies with sites.
Qualifications:
- Bachelor’s degree in a relevant life science or healthcare field, master’s degree preferred.
- Relevant experience as Clinical Research Associate, Clinical Specialist or similar in the medical device or CRO industry.
- Good knowledge of GCP, ISO14155, ICH guidelines, and other relevant regulatory requirements.
- Proven experience in proctoring and site management preferred.
- Strong organizational skills and attention to detail.
- Good communication and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Proficiency in using CTMS and EDC software solutions.
Senior Clinical Research Associate employer: The Mullings Group
Contact Detail:
The Mullings Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Clinical Research Associate
✨Tip Number 1
Familiarize yourself with the latest advancements in minimally invasive PCI techniques and the specific medical device our client is developing. This knowledge will not only help you during interviews but also demonstrate your genuine interest in the role.
✨Tip Number 2
Network with professionals in the clinical research and medical device fields. Attend relevant conferences or webinars to connect with industry experts, which can provide valuable insights and potentially lead to referrals for the position.
✨Tip Number 3
Prepare to discuss your experience with GCP, ISO14155, and ICH guidelines in detail. Be ready to share specific examples of how you've ensured compliance and data integrity in previous roles, as this will be crucial for the Senior Clinical Research Associate position.
✨Tip Number 4
Showcase your proctoring experience by preparing case studies or examples where you successfully trained staff or managed clinical trials. Highlighting these experiences will set you apart from other candidates and align with the responsibilities of the role.
We think you need these skills to ace Senior Clinical Research Associate
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Clinical Research Associate position. Understand the responsibilities and qualifications required, especially the importance of proctoring and clinical trial management.
Tailor Your CV: Customize your CV to highlight relevant experience in clinical research, particularly in medical devices or CROs. Emphasize your knowledge of GCP, ISO14155, and ICH guidelines, as well as any proctoring experience.
Craft a Compelling Cover Letter: Write a cover letter that connects your background and skills to the specific needs of the role. Mention your experience with training staff, managing clinical trials, and ensuring compliance with regulatory requirements.
Highlight Soft Skills: In your application, don't forget to showcase your strong organizational skills, attention to detail, and ability to work both independently and collaboratively. These are crucial for success in a fast-paced clinical environment.
How to prepare for a job interview at The Mullings Group
✨Showcase Your Clinical Expertise
Make sure to highlight your relevant experience in clinical research, especially in the medical device or CRO industry. Discuss specific projects you've worked on and how they relate to the responsibilities of the Senior Clinical Research Associate role.
✨Demonstrate Proctoring Skills
Since proctoring is a key responsibility, be prepared to discuss your previous experiences in training staff and supervising clinical workflows. Share examples of how you ensured quality data collection and compliance during trials.
✨Familiarize Yourself with Regulatory Standards
Brush up on GCP, ISO14155, and ICH guidelines. Be ready to discuss how you have applied these standards in past roles, as well as your approach to ensuring compliance during audits and inspections.
✨Emphasize Collaboration and Communication
This role requires working closely with various stakeholders. Prepare to share examples of how you've successfully collaborated with investigators, site staff, and CROs to resolve issues and ensure timely data collection.
