Senior Clinical Research Associate
Senior Clinical Research Associate

Senior Clinical Research Associate

Bolton Full-Time 48000 - 72000 £ / year (est.) No home office possible
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At a Glance

  • 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

Join a pioneering company at the forefront of medical innovation, where your role as a Senior Clinical Research Associate will not only contribute to groundbreaking advancements in heart attack treatment but also offer you a collaborative and supportive work environment. With a strong emphasis on employee growth, we provide comprehensive training and development opportunities, ensuring you thrive in your career while making a meaningful impact on patient outcomes across Europe. Experience the unique advantage of working with cutting-edge technology in a culture that values teamwork, integrity, and excellence.
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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 potential colleagues and learn more about the industry trends, which can give you an edge in discussions during the hiring process.

✨Tip Number 3

Prepare to discuss your experience with GCP, ISO14155, and ICH guidelines in detail. Be ready to provide examples of how you've ensured compliance in previous roles, as this will be crucial for the responsibilities outlined in the job description.

✨Tip Number 4

Showcase your proctoring and site management experience by preparing specific scenarios where you successfully trained staff or resolved issues at clinical sites. Highlighting these experiences will align well with the expectations for the Senior Clinical Research Associate position.

We think you need these skills to ace Senior Clinical Research Associate

Clinical Trial Management
Proctoring Skills
Site Management
Good Clinical Practice (GCP)
ISO 14155
ICH Guidelines
Data Management
Electronic Data Capture (EDC) Software
Clinical Trial Monitoring
Regulatory Compliance
Training and Education
Attention to Detail
Communication Skills
Interpersonal Skills
Organizational Skills

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, and think about how your experience aligns with these.

Tailor Your CV: Customize your CV to highlight relevant experience in clinical research, proctoring, and site management. Emphasize your knowledge of GCP, ISO14155, and ICH guidelines, as well as any specific software proficiencies.

Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical research and your understanding of the medical device industry. Mention specific experiences that demonstrate your ability to manage clinical trials and support site staff effectively.

Highlight Soft Skills: In your application, emphasize your strong organizational skills, attention to detail, and ability to communicate effectively. These soft skills are crucial for the role and should be evident in your application materials.

How to prepare for a job interview at The Mullings Group

✨Showcase Your Clinical Knowledge

Make sure to highlight your understanding of clinical trial processes, especially in relation to medical devices. Be prepared to discuss GCP, ISO14155, and ICH guidelines, as these are crucial for the role.

✨Demonstrate Proctoring Experience

Since proctoring is a key responsibility, share specific examples from your past experiences where you successfully trained staff or managed site workflows. This will show your capability in overseeing clinical activities.

✨Emphasize Communication Skills

Effective communication is vital in this role. Prepare to discuss how you've collaborated with investigators and site staff in the past to resolve issues and ensure data integrity.

✨Prepare for Scenario-Based Questions

Expect questions that assess your problem-solving skills in real-time clinical situations. Think of scenarios where you had to make quick decisions during live cases and how you ensured compliance with regulatory requirements.

Senior Clinical Research Associate
The Mullings Group
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  • Senior Clinical Research Associate

    Bolton
    Full-Time
    48000 - 72000 £ / year (est.)

    Application deadline: 2027-03-01

  • T

    The Mullings Group

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