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- Tasks: Conduct site monitoring visits and ensure compliance with regulations.
- Company: Join a leading organization in clinical research dedicated to improving patient outcomes.
- Benefits: Gain hands-on experience, flexible travel opportunities, and a chance to impact healthcare.
- Why this job: Be part of a dynamic team that drives innovation in clinical trials and patient care.
- Qualifications: Must have 6+ months of independent monitoring experience and a life science degree.
- Other info: Opportunities for growth and collaboration with experienced professionals in the field.
The predicted salary is between 36000 - 60000 £ per year.
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Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
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Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
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Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
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Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
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Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase
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Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
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Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
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Collaborate and liaise with study team members for project execution support as appropriate
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If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis
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6+ months Experience of independent on-site monitoring in the UK
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Monitoring experience of Oncology, Cardiovascular, Respiratory, Diabetic, Immunology or Renal therapeutic areas
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Life science degree educated or equivalent industry experience
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Flexibility to travel to sites as required
Clinical Research Associate 2 employer: Pharmiweb
Contact Detail:
Pharmiweb Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate 2
✨Tip Number 1
Make sure to highlight your experience with site monitoring in your conversations. Discuss specific examples of how you've successfully managed site visits and adhered to GCP and ICH guidelines.
✨Tip Number 2
Familiarize yourself with the therapeutic areas mentioned in the job description, especially Oncology and Cardiovascular. Being able to speak knowledgeably about these areas can set you apart during discussions.
✨Tip Number 3
Demonstrate your communication skills by preparing to discuss how you've established lines of communication with study sites in the past. Share strategies that helped manage project expectations effectively.
✨Tip Number 4
Be ready to talk about your experience with regulatory submissions and approvals. Highlight any specific challenges you've faced and how you overcame them to ensure compliance and progress in studies.
We think you need these skills to ace Clinical Research Associate 2
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Clinical Research Associate 2 position. Understand the key responsibilities and required qualifications, especially the importance of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience with site monitoring, particularly in Oncology, Cardiovascular, Respiratory, Diabetic, Immunology, or Renal therapeutic areas. Provide specific examples of your independent on-site monitoring experience in the UK.
Showcase Your Skills: Demonstrate your ability to manage project expectations and communicate effectively with study sites. Highlight any experience you have in developing subject recruitment plans and managing regulatory submissions.
Tailor Your Application: Customize your application materials to reflect the specific requirements of the job. Use keywords from the job description to align your skills and experiences with what the company is looking for.
How to prepare for a job interview at Pharmiweb
✨Know Your Guidelines
Familiarize yourself with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Being able to discuss these in detail will show your understanding of the regulatory landscape and how it applies to the role.
✨Demonstrate Monitoring Experience
Prepare to share specific examples from your previous monitoring experiences, especially in Oncology, Cardiovascular, or other relevant therapeutic areas. Highlight how you managed site visits and addressed any challenges that arose.
✨Showcase Communication Skills
Effective communication is key in this role. Be ready to discuss how you've established lines of communication with study sites and how you handled ongoing project expectations and issues.
✨Discuss Recruitment Strategies
Be prepared to talk about your experience with subject recruitment plans. Share any strategies you've implemented to enhance predictability and how you tracked progress against project needs.
