Clinical Research Associate

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Offer guidance, oversight, and constructive feedback to the CRA team to guarantee compliance with project scope, SOPs, timelines, and budgetary constraints.

• Assess monitoring visit reports and conduct co-monitoring and evaluation visits as necessary.

• Ensure timely and appropriate visits to investigator sites.

• Collaborate with relevant cross-functional departments to facilitate negotiation and resolve issues related to clinical trial monitoring.

• Aid in the creation of study-specific Monitoring Plans and training presentations as required.

• Execute qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring accurate documentation of monitoring activities.

• Maintain consistent communication with study sites to ensure compliance with protocol/GCP, evaluate patient accrual rates, and address sponsor inquiries.

⛳️ Requirements

• Degree in a scientific health field.

• Certified Monitor in accordance with the Italian CRO decree dated 15 Nov 2011.

• Capacity to establish and nurture positive relationships with Sponsors, Site, and Project Team members.

• Ability to independently manage monitoring activities.

• Quality-focused; demonstrated capability to be meticulous, thorough, and detail-oriented.

• Strong organizational abilities and capacity to multitask while performing effectively in a fast-paced setting.

• Proficient analytical, negotiation, meeting management, cross-functional teamwork, and leadership skills.

• Willingness to travel.

• Familiarity with clinical research, ICH GCP, and local regulations.

• Understanding of regulatory and ethical standards.

🏝️ Benefits

• Opportunities for professional development.

• Global travel opportunities.

• Flexible work arrangements.

• A creative working environment.