At a Glance
- Tasks: Lead clinical studies, ensuring compliance and building strong site relationships.
- Company: A leading company in high-quality clinical research with a global impact.
- Benefits: Competitive pay, mentorship opportunities, and a collaborative work environment.
- Other info: Travel 65-75% of the time, with opportunities for growth and development.
- Why this job: Make a difference in patient safety while advancing your career in clinical research.
- Qualifications: Bachelor's degree and experience in site management required.
The predicted salary is between 35000 - 45000 £ per year.
Location: Midlands
Travel: Approximately 65–75% (about 2–3 days per week, domestic and international)
About our company
Our company is committed to advancing high-quality clinical research that upholds ICH/GCP standards and local regulatory requirements. We collaborate across global and regional teams to deliver studies with excellence, integrity, and patient safety at the core.
Role Overview
We are seeking a highly skilled Clinical Research Associate (CRA) to lead performance and compliance for assigned protocols and sites within the South East. Under the oversight of the CRA Manager or Clinical Research Director (CRD), you will serve as the primary site contact throughout all phases of clinical studies, ensuring rigorous adherence to ICH/GCP, local regulations, our company policies and procedures, quality standards, and adverse event reporting requirements.
Key Responsibilities
- Build and sustain strong relationships with investigative sites across all trial phases.
- Perform site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws/regulations, protocol, site monitoring plans, and related documents.
- Develop deep understanding of study protocols and procedures.
- Coordinate cross-functional tasks to achieve Site Ready status.
- Participate in site selection and validation; provide informed input to decisions.
- Conduct remote and on-site monitoring to ensure data integrity (complete, accurate, unbiased) and protection of subjects’ rights, safety, and well-being.
- Execute validation, initiation, monitoring, and close-out visits; document clear, comprehensive visit and non-visit reports in a timely manner.
- Collect, review, and monitor regulatory documentation for start-up, maintenance, and close-out.
- Communicate proactively with investigators and site staff on protocol conduct, recruitment/retention, deviations, regulatory findings, audits/inspections, and site performance.
- Identify, assess, and resolve site performance, quality, or compliance issues; elevate appropriately per the CRA escalation pathway in collaboration with CRA Manager, CRM, TA Head, and CRD.
- Partner with internal teams (country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ) and external stakeholders (vendors, IRB/IEC, regulatory authorities).
- Maintain accurate, timely documentation in CTMS, eTMF, and other systems.
- Act as a process SME: share best practices, drive continuous improvement, and deliver training.
- Support and/or lead audit/inspection activities.
- Contribute to country strategy by identifying and onboarding potential new sites; build site capabilities.
- Mentor and buddy junior CRAs; conduct co-monitoring and quality control visits where appropriate.
Travel Requirements
Ability to travel domestically and internationally approximately 65–75% of working time (about 2–3 days per week). Valid driver’s license preferred; required in certain countries.
Qualifications, Skills, and Experience
- Fluent in English, with strong written and verbal communication skills and the ability to present technical information effectively.
- Robust knowledge of clinical research, trial phases, ICH/GCP, and local clinical research regulations and guidelines; ability to work within global, country, and regional frameworks.
- Demonstrated mentoring and leadership capability.
- Hands-on knowledge of Good Documentation Practices.
- Proven site management expertise, including independent oversight of site performance and patient recruitment.
- High-level monitoring skills with sound, independent professional judgment.
- Strong IT proficiency (MS Office and clinical applications across computer, tablet, and mobile); adaptable to new tools.
- Ability to interpret data/metrics and take appropriate action, including in virtual settings.
- Experience conducting site motivation visits to boost enrollment.
- Solution-oriented approach to complex issues; capable of root-cause analysis and implementing preventive/corrective actions.
- Ability to mentor junior CRAs and perform co-monitoring visits.
Behavioral Competencies
- Excellent time management, organization, interpersonal skills, conflict management, and problem solving.
- High independence across multiple protocols, sites, and therapy areas.
- Strong sense of accountability and urgency; able to prioritize and multitask in changing environments.
- Effective in a matrixed, multicultural setting; fosters culturally sensitive relationships.
- Customer-focused mindset with high standards of quality and compliance.
- Positive, growth-oriented, self-driven, and professional demeanor aligned with company values.
Education and Experience
Bachelor’s degree (or higher) with extensive direct site management (monitoring) in bio/pharma/CRO.
What We Offer
- Opportunity to shape clinical research at high-performing sites and contribute to global development programs.
- A collaborative environment with growth, mentorship, and continuous improvement.
- Competitive compensation and benefits.
Clinical Research Associate - Midlands employer: Merck Gruppe - MSD Sharp & Dohme
Our company is an exceptional employer for Clinical Research Associates in the Midlands, offering a dynamic and collaborative work environment that prioritises employee growth and mentorship. With competitive compensation and benefits, we empower our team to shape high-quality clinical research while ensuring patient safety and compliance with global standards. The role involves significant travel, providing opportunities to engage with diverse sites and contribute to impactful global development programmes.
Contact Details:
Merck Gruppe - MSD Sharp & Dohme Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Clinical Research Associate - Midlands
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. Building relationships can lead to job opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for interviews by researching the company and understanding their values. Be ready to discuss how your experience aligns with their mission of advancing high-quality clinical research.
✨Tip Number 3
Showcase your site management skills during interviews. Share specific examples of how you’ve ensured compliance and built strong relationships with investigative sites in past roles.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Clinical Research Associate - Midlands
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Clinical Research Associate role. Highlight your relevant experience in clinical research, site management, and any specific skills that match the job description. We want to see how you fit into our team!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your background aligns with our company values. Keep it concise but impactful – we love a good story!
Showcase Your Communication Skills:Since strong communication is key in this role, make sure your application reflects your written and verbal skills. Use clear language and structure in your CV and cover letter, as this will give us a taste of how you communicate in a professional setting.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing candidates who take the initiative!
How to prepare for a job interview at Merck Gruppe - MSD Sharp & Dohme
✨Know Your Protocols Inside Out
Before the interview, make sure you have a solid understanding of the clinical research protocols relevant to the role. Familiarise yourself with ICH/GCP standards and local regulations, as these will likely come up during your discussion. Being able to speak confidently about these topics will show that you're serious about the position.
✨Showcase Your Site Management Skills
Prepare examples from your past experiences where you've successfully managed sites or led monitoring activities. Highlight specific challenges you faced and how you overcame them. This will demonstrate your hands-on knowledge and ability to handle site performance and compliance effectively.
✨Emphasise Your Communication Skills
As a Clinical Research Associate, you'll need to communicate with various stakeholders. Be ready to discuss how you've built relationships with investigators and site staff in the past. Use examples that showcase your strong written and verbal communication skills, especially in presenting technical information.
✨Be Ready for Travel Discussions
Since the role requires significant travel, be prepared to discuss your flexibility and willingness to travel domestically and internationally. Share any previous experiences where travel was a key part of your job, and how you managed it alongside your responsibilities.
