Clinical Research Associate – Multi-Sponsor

• Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits, on-site or remotely
• Evaluate site and site staff performance and provide recommendations regarding site-specific actions
• Communicate and escape serious issues to the project team and develop action plans
• Verify informed consent processes and documentation
• Assess subject/patient safety, clinical data integrity, protocol deviations/violations and pharmacovigilance issues
• Assess site processes and conduct source document review of site source documents and medical records
• Verify clinical data entered in case report forms is accurate and complete
• Resolve queries remotely and on site and guide site staff toward closure
• Use hardware and software for clinical study data review and capture
• Verify compliance with electronic data capture requirements
• Perform investigational product inventory, reconciliation and storage/security reviews as needed
• Verify investigational product dispensing and administration according to protocol
• Review Investigator Site Files and reconcile them with the Trial Master File
• Document activities through letters, trip reports, communication logs and other project documents
• Support subject/patient recruitment, retention and awareness strategies
• Track observations, ongoing status and action items to resolution
• Manage site-level activities and communications to meet project objectives, deliverables and timelines
• Act as primary liaison with study site personnel or collaborate with the Central Monitoring Associate
• Train assigned sites and project-specific site team members
• Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
• Participate in global clinical monitoring/project staff meetings and clinical training sessions
• Support audit readiness, audit preparation and follow-up actions

Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Good computer skills and ability to embrace new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular basis
• Working knowledge of relevant regulations and company SOPs/processes
• Ability to comply with clinical protocols, regulatory requirements, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP)
• Ability to complete assigned training as required
• Core Competencies

Demonstrates expertise in clinical site management, including site qualification, monitoring, and compliance with Good Clinical Practice (GCP) and regulatory requirements.

Proficient in data integrity assessment, patient safety evaluation, and effective communication with site personnel.

• Highest-signal resume keywords
• Site Qualification
• Good Clinical Practice (GCP)
• Clinical Data Integrity
• Patient Safety Assessment
• Site Management
• ATS Optimization Keywords
• Hard Skills
• Clinical Monitoring
• Source Document Review
• Electronic Data Capture
• Investigational Product Management
• Protocol Compliance
• Soft Skills
• Excellent Communication
• Interpersonal Skills
• Presentation Skills

Certifications & Qualifications

• Bachelor’s Degree
• Registered Nurse (RN)
• Industry Keywords
• ICH Guidelines
• Pharmacovigilance
• Clinical Protocols
• Audit Readiness
• Site Staff Training
• Tools & Technologies
• Clinical Study Data Review Software
• Data Capture Hardware
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