At a Glance
- Tasks: Lead clinical research studies and ensure compliance with regulations while building strong site relationships.
- Company: Join MSD, a diverse employer committed to advancing clinical research.
- Benefits: Enjoy competitive pay, growth opportunities, and a collaborative work environment.
- Other info: Travel 65-75% of the time, with mentorship and continuous improvement opportunities.
- Why this job: Make a real impact in healthcare by shaping clinical research at high-performing sites.
- Qualifications: Bachelor's degree and experience in clinical site management required.
The predicted salary is between 37000 - 46000 £ per year.
This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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 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; escalate appropriately.
- Partner with internal teams and external stakeholders.
- 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.
- Robust knowledge of clinical research, trial phases, ICH/GCP, and local clinical research regulations and guidelines.
- 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).
- Ability to interpret data/metrics and take appropriate action.
- Experience conducting site motivation visits to boost enrollment.
- Solution-oriented approach to complex issues.
- 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.
- Effective in a matrixed, multicultural setting.
- 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.
How to apply: Please submit your resume/CV and a brief cover letter outlining your relevant monitoring experience and site leadership achievements.
Clinical Research Associate - Midlands employer: MSD
Our company is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the field of animal health technology. With a strong focus on employee growth, we provide opportunities for professional development and meaningful contributions to global livestock management solutions. Located in a vibrant area, our team enjoys flexible remote work arrangements and comprehensive benefits, ensuring a supportive environment for all employees.
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 your connections in the clinical research field, attend industry events, and join relevant online groups. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨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, especially around patient safety and compliance. Show them you're not just a fit for the role, but for their culture too!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your site management skills and how you've tackled challenges in past roles.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you're genuinely interested in joining our team and contributing to high-quality clinical research.
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 makes you a great fit for this position. Keep it concise but impactful – we love a good story!
Showcase Your Skills:Don’t forget to highlight your strong communication skills and your ability to work independently across multiple protocols. We’re looking for someone who can manage relationships effectively, so give us examples of how you've done this in the past.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re serious about joining our team at StudySmarter!
How to prepare for a job interview at MSD
✨Know Your Protocols Inside Out
Before the interview, make sure you have a solid understanding of the clinical research protocols and procedures relevant to the role. This will not only help you answer questions confidently but also demonstrate your commitment to compliance with ICH/GCP standards.
✨Showcase Your Site Management Skills
Be prepared to discuss your previous experiences in site management and monitoring. Highlight specific examples where you successfully managed site performance or resolved compliance issues, as this will show your potential employer that you can handle the responsibilities of the role effectively.
✨Demonstrate Strong Communication Abilities
As a Clinical Research Associate, you'll need to communicate with various stakeholders. Practice articulating complex information clearly and concisely. You might even want to prepare a few scenarios where you had to navigate challenging conversations with site staff or investigators.
✨Emphasise Your Adaptability and Problem-Solving Skills
Given the dynamic nature of clinical trials, it's crucial to showcase your ability to adapt to changing environments and solve problems on the fly. Prepare examples of how you've tackled unexpected challenges in past roles, especially those that required quick thinking and collaboration with cross-functional teams.
