Clinical Research Associate

1 month ago

London, Greater London, United Kingdom Alira Health Full time
About the Role

We are seeking an experienced and skilled Senior Clinical Research Associate to join our clinical monitoring team at Alira Health. As a Sr. CRA, you will play a vital role in ensuring the successful execution of clinical trials by providing oversight, guidance, and leadership to our site-based staff.

Responsibilities
  • Lead Clinical Monitoring Activities: Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
  • Monitoring Visit Expertise: Review monitoring visit reports, conduct co-monitoring and evaluation visits as needed, and ensure timely completion of on-site and remote monitoring activities.
  • Site Management: Ensure proper management of investigator sites, including negotiation/issue resolution for clinical trial monitoring related issues, and provision of monthly billing information to finance team as required.
  • Budget Management: For monitoring stand-alone projects, manage study budget and act as referent for the sponsor.
  • Compliance and Quality Assurance: Ensure integrity of CRF data through meticulous and thorough source document review and verification, and maintain quality control and verification of documents collected at sites for eTMF/TMF.
Requirements

To be successful in this role, you must have:

  • Minimum 3 years of experience in the pharmaceutical / biotechnology / CRO industry with 2 years of clinical monitoring experience and 1 year of management experience (US); or minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities (EU).
  • Strong Analytical and Leadership Skills: Proven ability to analyze complex data, identify problems, and develop effective solutions; excellent leadership skills, with the ability to guide and motivate a team of CRAs.
  • Technical Competencies: Strong command of English, both written and verbal (US); strong command of Local language, both written and verbal, in the country where monitoring activities are performed (EU); excellent communication and interpersonal skills with customer service orientation.
What We Offer

We offer a competitive salary range: $80,000-$110,000 per annum, depending on your location, qualifications, and experience. Our benefits package includes professional development opportunities, flexible working hours, and a comprehensive health insurance plan.

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