Lead Clinical Research Associate
Lead Clinical Research Associate

Lead Clinical Research Associate

Warrington Full-Time 48000 - 84000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead and oversee clinical trial sites, ensuring compliance and safety.
  • Company: Join a fully remote company dedicated to advancing clinical research.
  • Benefits: Enjoy flexible remote work and opportunities for professional growth.
  • Why this job: Make a real impact in healthcare while working in a dynamic team environment.
  • Qualifications: 4+ years of CRA experience and a degree in a scientific or healthcare field.
  • Other info: Ideal for those passionate about clinical trials and regulatory compliance.

The predicted salary is between 48000 - 84000 £ per year.

The Lead Clinical Research Associate is a critical core team member responsible for the oversight of a defined set of clinical trial sites within a region. They oversee clinical trial sites to ensure compliance with the Monitoring Plan, protocol, Good Clinical Practice (GCP), and local regulations. They serve as the primary point of contact for the site and act as the primary liaison between the site and my client. The CRA will conduct site visits, oversee essential document collection and review, and prepare trip reports to summarise monitoring activities.

Essential Functions of the job:

  • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH GCP, protocol, and company SOP compliance.
  • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.
  • Identifies potential factors which might affect subject safety and clinical data integrity, immediately communicates/escalates serious issues to the project team and develops action plans.
  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Verifies site processes to obtain informed consent have been adequately performed and documents for each subject.
  • Assesses site processes, conducts source document review, and verifies site compliance with data entry requirements according to the Monitoring Plan.
  • Performs Source Data Review/Source Data Verification for assigned clinical trial sites.
  • Reviews investigational product inventory, reconciliation and storage at trial sites, ensuring GCP guidelines are followed.
  • Reviews the Investigator Site File for accuracy and completeness.
  • Provides site and regional metrics into trackers to support project-level report generation.
  • Understands project scope, budgets, and timelines for own activities in the clinical operations team; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met.
  • Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
  • Provides guidance at the site level towards audit readiness standards and supports preparation for audit and required follow-up actions.

Qualifications:

  • Minimum of 4 years of Clinical Monitor/CRA experience in a biotech, pharmaceutical, or CRO capacity.
  • B.S., scientific or healthcare degree preferred.
  • Strong understanding of clinical trial processes and regulatory requirements, including ICH GCP guidelines.
  • Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
  • Excellent organisational and communication skills.
  • Ability to work collaboratively in a fast-paced, dynamic environment.
  • Demonstrated ability to manage multiple tasks simultaneously and to adapt to changing priorities to meet deadlines.

Computer/Technology Skills:

  • Proficient with Microsoft Office Suite, Project Management tools.
  • Understanding of clinical trial systems, including EDC, IRT, CTMS, and TMF platforms, is a plus.

Lead Clinical Research Associate employer: Hlx Life Sciences

As a fully remote company based in the UK, we pride ourselves on fostering a supportive and flexible work culture that prioritises employee well-being and professional growth. Our Lead Clinical Research Associates benefit from comprehensive training opportunities, a collaborative environment, and the chance to make a meaningful impact on clinical trials while enjoying the work-life balance that remote work offers.
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Contact Detail:

Hlx Life Sciences Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Lead Clinical Research Associate

✨Tip Number 1

Network with professionals in the clinical research field. Attend industry conferences, webinars, or local meetups to connect with others who may have insights into the role of a Lead Clinical Research Associate and can provide valuable referrals.

✨Tip Number 2

Familiarise yourself with the latest ICH GCP guidelines and any recent changes in regulations. Being well-versed in these areas will not only boost your confidence but also demonstrate your commitment to compliance during interviews.

✨Tip Number 3

Prepare for potential interview questions by reviewing common scenarios faced by Clinical Research Associates. Think about how you would handle site management challenges or ensure compliance, as this will showcase your problem-solving skills.

✨Tip Number 4

Showcase your organisational skills by discussing specific tools or methods you use to manage multiple tasks. Highlighting your proficiency with project management tools can set you apart from other candidates.

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

Clinical Trial Management
Good Clinical Practice (GCP)
Site Monitoring
Regulatory Compliance
Source Data Review
Report Writing
Project Management
Communication Skills
Organisational Skills
Problem-Solving Skills
Team Collaboration
Adaptability
Clinical Research Knowledge
Data Integrity Assessment
Training and Development

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in clinical monitoring and research. Emphasise your understanding of ICH GCP guidelines and any specific achievements in previous roles that align with the responsibilities of a Lead Clinical Research Associate.

Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for clinical research and your ability to manage multiple tasks. Mention specific examples from your past experiences that demonstrate your skills in site management and compliance with regulatory requirements.

Highlight Key Skills: In your application, clearly outline your organisational and communication skills. Provide examples of how you've successfully collaborated in fast-paced environments and managed site-level activities to meet project objectives.

Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any grammatical errors or typos. A polished application reflects your attention to detail, which is crucial in clinical research.

How to prepare for a job interview at Hlx Life Sciences

✨Know Your Clinical Trial Regulations

Make sure you have a solid understanding of ICH GCP guidelines and local regulations. Be prepared to discuss how you've applied these in your previous roles, as this will demonstrate your expertise and commitment to compliance.

✨Showcase Your Organisational Skills

As a Lead Clinical Research Associate, you'll need to manage multiple sites and tasks. Prepare examples that highlight your organisational skills and ability to prioritise effectively, especially in fast-paced environments.

✨Prepare for Scenario-Based Questions

Expect questions that assess your problem-solving abilities. Think of scenarios where you had to address compliance issues or improve site performance, and be ready to explain your thought process and actions taken.

✨Demonstrate Strong Communication Skills

Since you'll be the primary liaison between sites and the company, it's crucial to showcase your communication skills. Practice articulating complex information clearly and concisely, and be ready to discuss how you handle difficult conversations.

Lead Clinical Research Associate
Hlx Life Sciences
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