Senior Clinical Research Associate

Responsibilities

• Independently schedules and conducts remote and on-site monitoring visits.
• Conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/IP/ID storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan.
• Documents observations and monitoring activities in a site visit report.
• Facilitates and oversees Action Item resolution post visit.
• Ensures compliance with protocol/clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.
• Provides training and retraining to site staff.
• Identifies areas requiring follow-up and improvement at each clinical study site and reports findings.
• Serves as point of contact for study site personnel.
• Assists with the development and/or review of study-related materials.
• Attends project team meetings and provides updates on project status and site-specific performance.
• Collaborates with internal and external colleagues to meet project objectives and timelines.
• Participates in Investigator Meetings or other client meetings as needed.
• Assists with filing and archiving of study documents.
• Assists in preparing sites for audits and provides support and cooperation during audits/inspections (including translation to Auditor if needed).
• May assist with coordination of clinical study supplies.
• May assist with submission of applications/notifications to IRB/EC/Regulatory Authority.
• May assist with site recruitment oversight activities.
• Performs site management activities as required.

Qualifications

• Bachelor's Degree in a Scientific discipline or equivalent work experience
• 4-6 years monitoring experience (on-site and remote)
• Proficient with MS Office Suite
• Excellent computer and organizational skills
• Exceptional level of attention to detail required
• Ability to work on varying projects and exercise critical thinking with minimal oversight
• Self-starter who can work remotely and a team player who can work cross-functionally with minimal oversight
• Expertise in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines, as required per their role as a CRA
• Excellent organizational, interpersonal, and communication skills both oral and written
• Demonstrated problem-solving skills, self-motivated, and adaptable to a dynamic environment
• Expertise in prioritization, problem-solving, organization, critical thinking, decision-making, time management, and planning activities