Clinical Research Associate

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

📋 Description

• Independently carry out site monitoring responsibilities for clinical trials.

• Provide leadership, oversight, and guidance in the management and execution of clinical trials.

• Ensure compliance with protocols, quality standards, adherence to SOPs, timelines, and budget constraints.

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

• Ensure timely visits to investigator sites.

• Coordinate with cross-functional departments to address clinical trial monitoring issues.

• Assist in the development of Monitoring Plans and training presentations.

• Organize and collect site ethics documentation and assist in site contract negotiations.

• Provide monthly billing details to the finance team.

• Manage study budgets and serve as the sponsor referent for independent projects.

• Conduct qualification, initiation, interim, and close-out visits both remotely and onsite.

• Prepare detailed monitoring visit reports documenting site issues, resolutions, protocol deviations, study progress, and enrollment.

• Review source documents and verify the integrity of CRF data.

• Execute quality control and document verification for eTMF/TMF.

• Oversee investigational product accountability.

• Review regulatory binders for sites.

• Maintain communication with study sites, evaluate patient accrual, and respond to sponsor inquiries.

• Ensure adherence to ICH GCP, FDA regulations, and company/sponsor SOPs.

• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs.

• Resolve data discrepancies by collaborating with in-house CRAs/CTC and data management teams.

• Identify issues at sites and formulate problem-solving strategies.

• Prepare for audits at study sites.

• Train and onboard new CRAs while mentoring existing ones.

• Collaborate on the development and maintenance of CTMS.

• Manage conflicting priorities and undertake additional assigned duties.

⛳️ Requirements

• EU: Degree in a scientific health field.

• EU (Italy): Certified Monitor in accordance with the Italian CRO decree dated 15Nov2011.

• Ability to cultivate and maintain positive relationships with Sponsors, Sites, and Project Team members.

• Capability to autonomously oversee monitoring activities.

• Quality-focused; meticulous, thorough, and detail-oriented.

• Strong organizational abilities; proficient in multitasking and functioning effectively in a fast-paced environment.

• Competence in managing priorities, organizing time, and solving problems.

• Strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills.

• Willingness to travel.

• Ability to manage stress effectively.

• Professional, reliable, and disciplined.

• Skillful in addressing unstructured or ambiguous challenges.

• Proficient in the local language, both written and verbal, in the country where monitoring activities take place.

• Excellent communication and interpersonal skills with a focus on customer service.

• Good computer proficiency, including experience with clinical trial management systems, clinical trial databases, and electronic data capture.

• Self-motivated individual able to excel in a collaborative and less structured team environment.

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

• Knowledge of regulatory and ethical standards.

• EU: Sufficient English language skills.

• Bachelor's degree in Biology or Life Sciences.

🏝️ Benefits

• Flexible remote work arrangement.

• Opportunity for global team collaboration across various time zones.