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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research monitoring, regulatory compliance, and effective communication within cross-functional teams. Proficient in managing clinical trial documentation and ensuring adherence to state and federal regulations.
Highest-signal resume keywords
Clinical Research Associate (CRA) ExperienceDirect Monitoring Experience with Medical Device StudiesRegulatory Compliance KnowledgeExperience Using Smartsheet and Microsoft 365Ability to Prepare and Deliver Project Communications
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Documentation ManagementSite MonitoringData Review and Query ResolutionRegulatory Document PreparationFeasibility AssessmentRemedial Training ImplementationCase Report Form ReviewOperational Process ReviewDevice Preparation and Shipment CoordinationClinical Study Site Initiation
Soft Skills
Problem Identification and ResolutionPrioritization and PlanningCommunication SkillsCollaborationAdaptability
Tools & Technologies
SmartsheetMicrosoft CopilotMicrosoft 365 Applications
Industry Keywords
Clinical ResearchBiomedical IndustryMedical Device IndustryState and Federal RegulationsInvestigative SitesSite FeasibilityClinical Study MonitoringTrial Master FileSite Personnel TrainingCross-Functional Teams
About the role
Key responsibilities & impact- Prepare, collect, distribute, and maintain trial master file and regulatory documents at investigative sites
- Conduct pre-study site visits and review site feasibility and operational processes
- Prepare reports and participate in selecting investigators and study sites
- Conduct clinical study site initiation visits and train site personnel on sponsor and regulatory requirements
- Conduct site monitoring visits and follow up on significant problems and issues
- Ensure clinical studies comply with state and federal regulations, guidelines, and policies
- Review site files, records, case report forms, and source documents for completeness, accuracy, consistency, and compliance
- Identify deficiencies and discrepancies and provide remedial training or initiate corrective action
- Review and resolve case report form queries and data issues
- Collaborate with the Clinical Project Manager, cross-functional study teams, and internal and external research partners
- Assist with device preparation, shipment coordination, and accountability records
Requirements
What you’ll need- Bachelor’s degree or higher from an accredited institution and three (3) years of clinical research, biomedical, or medical device industry experience, including two (2) years of direct Clinical Research Associate (CRA) experience conducting clinical study monitoring activities; OR High School Diploma/GED and seven (7) years of relevant industry experience, including five (5) years of direct CRA experience conducting clinical study monitoring activities
- Direct CRA monitoring experience with medical device clinical studies
- Experience working in a hospital or clinical setting or medical laboratory
- Experience using Smartsheet, Microsoft Copilot, and Microsoft 365 applications
- Experience preparing and delivering verbal, written, and presentation communications regarding project status, issues, and escalations
- Ability to identify problems, evaluate potential solutions, and support resolution of business or project issues
- Ability to prioritize, plan, track, and evaluate deliverables against established requirements and timelines
- Ability to manage multiple concurrent tasks and adjust priorities based on changing business needs and deadlines
- Must be legally authorized to work in the country of employment without sponsorship for employment visa status
Benefits
Comp & perks- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits