Senior Clinical Research Associate

Alexion Pharmaceuticals • Boston, MA

436d • $111,445 - $167,167

About The Position

The Senior Clinical Research Associate (Sr. CRA) is responsible for overseeing the delivery of clinical studies at allocated sites, ensuring compliance with international guidelines and local regulations. The Sr. CRA collaborates closely with other CRAs and the Country Operations Management Team to meet study commitments efficiently. This role involves monitoring study conduct, training site staff, and managing site performance to ensure successful study outcomes.

Requirements

• Minimum of 4 years of CRA monitoring experience.
• Bachelor's degree in a related discipline, preferably in life science.
• Excellent knowledge of international guidelines ICH-GCP and relevant local regulations.
• Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
• Excellent understanding of Clinical Study Management including monitoring, study drug handling, and data management.
• Excellent attention to detail and written/verbal communication skills.
• Excellent collaboration and interpersonal skills with good negotiation skills.
• Demonstrates flexibility in schedule and willingness to travel (up to 70% during busy periods).
• Valid driving license (if required in the country).
• Solid knowledge of clinical development processes with a strong emphasis on monitoring.

Nice To Haves

• Ability to work in a remote collaborative environment and matrix reporting structure.
• Positive approach to managing change and improving performance.
• Ability to prioritize and manage multiple tasks with conflicting deadlines.
• Proactivity and assertiveness in communication with stakeholders and sites.
• Understanding the impact of technology on projects and using appropriate systems/software.
• Team-oriented and flexible, able to respond quickly to shifting demands.
• Experience in all study phases and in rare medical conditions preferred.

Responsibilities

• Perform selection, initiation, interim monitoring, and closeout visits (remote and onsite) according to the Clinical Monitoring Plan (CMP).
• Drive performance at the sites and proactively identify and resolve study-related issues.
• Train, support, and advise Investigators and site staff on study-related matters, including Risk Based Quality Management (RBQM) principles.
• Develop recruitment plans with each site and manage enrollment to meet milestones.
• Document recruitment barriers and mitigation plans.
• Ensure monitoring KPIs are observed and remain within acceptable quality ranges.
• Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to the Principal Investigator.
• Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP and local requirements.
• Participate in regular QC checks of the eTMF.
• Accountable for study start-up and regulatory maintenance in some countries, including document preparation and submission to EC/IRB and Regulatory Authorities.
• Contribute to the nomination and selection of potential investigators and assist with feasibility activities.
• Collaborate with local Medical Affairs and other internal stakeholders as needed.
• Follow quality issue processes by escalating serious quality issues or compliance issues as required.
• Prepare for and collaborate on audits and regulatory inspections.

Benefits

• 401(k) plan
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage
• Short-term incentive bonus opportunity
• Eligibility to participate in equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree