Senior Clinical Research Associate - UK

ProPharma; Greater London; On-site; GBP 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior Clinical Research Associate to ensure clinical studies are conducted in compliance with protocols and regulations. In this pivotal role, you will conduct monitoring visits, manage investigational supplies, and communicate with various stakeholders to address study needs. This position offers a unique opportunity to contribute to significant advancements in patient health and wellness, working in a diverse and inclusive environment. If you are passionate about clinical research and thrive in a dynamic setting, this role is perfect for you.

Qualifications

• Over 5 years of experience as a Clinical Research Associate.
• Bachelor's degree or equivalent experience required.

Responsibilities

• Conduct clinical monitoring of assigned protocols and investigational sites.
• Manage investigational supplies and monitor trial progress.
• Communicate effectively with sites and project teams.

Skills

Excellent communication skills

Interpersonal skills

Presentation skills

Proficient in Microsoft Office

Knowledge of ICH guidelines

Organizational skills

Education

Bachelor's degree or equivalent experience

Tools

EDC

CTMS

IVRS

eTMF systems

Job description

Join to apply for the Senior Clinical Research Associate - UK role at ProPharma.

ProPharma has spent the past 20 years improving patient health and wellness by providing expert advice and solutions that empower biotech, med device, and pharmaceutical organizations to advance scientific breakthroughs and introduce new therapies. The company partners with clients through an advise-build-operate model across the entire product lifecycle, offering customizable consulting solutions in regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and R&D technology to de-risk and accelerate high-profile drug and device programs.

Role Overview

The Senior Clinical Research Associate is responsible for clinical monitoring of assigned protocols and investigational sites, ensuring studies are conducted and documented in accordance with protocols, SOPs, GCP, and regulatory requirements.

Essential Functions

1. Conduct monitoring visits (in person and remote), including site initiation, interim, and close-out visits, and complete monitoring reports per SOPs and regulations.
2. Perform study start-up activities in the US, including site identification, feasibility, documentation, and ethics submissions.
3. Develop study-specific monitoring documentation and train site personnel on protocol and documentation standards.
4. Review source documents and case report forms for accuracy and completeness, resolving data issues.
5. Manage investigational supplies, including dispensing, inventory, and reconciliation.
6. Monitor trial progress, including enrollment, protocol deviations, adverse events, and other site activities.
7. Oversee regulatory documentation accuracy and support sites with regulatory concerns.
8. Communicate effectively with sites, investigators, and project teams to address study needs.
9. Participate in meetings with internal and external stakeholders.
10. Perform other duties as assigned.

Skills and Abilities

• Excellent communication, interpersonal, and presentation skills.
• Proficient in Microsoft Office, EDC, CTMS, IVRS, and eTMF systems.
• Knowledge of local laws, regulations, ICH guidelines, and GCPs.
• Ability to prioritize, plan proactively, and work independently.
• Strong organizational skills and attention to detail.

Educational and Experience Requirements

• Bachelor's degree or equivalent experience.
• Over 5 years of experience as a Clinical Research Associate.

ProPharma values diversity, equity, and inclusion, fostering a workplace where everyone can be their authentic selves. We are committed to providing a safe and empowering environment for all employees.

Note: ProPharma Group does not accept unsolicited resumes from recruiters or third parties. Please do not contact via phone or email regarding this posting.