Snabbfakta
-
- London
Ansök senast: 2025-02-17
Senior Clinical Research Associate (CRA)
About the Role
We are seeking a highly experienced Senior Clinical Research Associate (CRA) to lead the execution of clinical trials across various therapeutic areas. The ideal candidate will have in-depth knowledge of Good Clinical Practice (GCP), local regulations, and clinical trial processes, ensuring the successful completion of projects within specified timelines and budgets. This role involves overseeing study sites, monitoring activities, and collaborating with cross-functional teams to ensure data integrity and compliance.
Key Responsibilities
Identify, select, and initiate trial sites while building strong relationships with investigators and site staff.
Conduct pre-study, initiation, interim monitoring, and close-out visits to ensure compliance with the protocol and regulatory guidelines.
Monitor the progress of clinical trials to ensure adherence to approved protocols, regulatory requirements, and timelines.
Review and verify source data, case report forms (CRFs), and other study documentation for accuracy and completeness.
Ensure that all trial activities comply with GCP, local regulations, and company SOPs.
Assist in the preparation and submission of required regulatory documents.
Identify, document, and resolve data discrepancies and deviations from the study protocol.
Collaborate with the data management team to ensure high-quality data collection and reporting.
Act as the primary liaison between the study sponsor, investigators, and clinical sites.
Support project managers, medical monitors, and other stakeholders in managing clinical trial deliverables.
Provide guidance, mentorship, and training to junior CRAs.
Stay updated with industry trends, GCP guidelines, and regulatory changes to share best practices.
Qualifications
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field (Master’s degree preferred).
Minimum of 5 years of experience in clinical research, with at least 2 years in a senior CRA role.
Thorough understanding of GCP, ICH guidelines, and local regulatory requirements.
Proven experience in managing multiple sites and trials across different phases (Phase I-IV).
Strong proficiency in clinical trial monitoring and site management.
Excellent written and verbal communication skills.
Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
Key Competencies
Strong analytical and problem-solving skills.
Exceptional organizational and multitasking abilities.
Ability to build and maintain effective relationships with site staff and stakeholders.
Flexibility to travel frequently to clinical sites as needed.
High level of attention to detail and a commitment to data accuracy.
What We Offer
Competitive salary and benefits package.
Opportunities for professional development and career progression.
A collaborative and innovative work environment.
The chance to contribute to impactful research and improve patient outcomes.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV.
STRAGO is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. STRAGO is acting as an Employment Agency in relation to this vacancy.
Fler jobb från Talent
