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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site monitoring, regulatory compliance, and project management within clinical research. Proficient in Good Clinical Practice (GCP) and adept at maintaining effective communication and relationships with study sites and team members.
Highest-signal resume keywords
Site Monitoring ExperienceGood Clinical Practice (GCP)Regulatory Requirements KnowledgeProject Management SkillsBachelor's Degree in Scientific Discipline
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site MonitoringRegulatory Submissions TrackingProtocol Training AdministrationData Query GenerationCRF CompletionSite Management DocumentationTherapeutic KnowledgeFinancial ManagementRecruitment PlanningProblem-Solving
Soft Skills
Written CommunicationVerbal CommunicationOrganizational SkillsTime ManagementRelationship Building
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointLaptop ComputerIPhoneIPad
Industry Keywords
Clinical ResearchInternational Conference on Harmonization (ICH)Trial Master FileInvestigator's Site FileStudy Start-Up Phase
About the role
Key responsibilities & impact- Perform site monitoring visits, including selection, initiation, monitoring, and close-out visits
- Adapt, drive, and track subject recruitment plans with study sites
- Administer protocol and study training to assigned sites
- Establish regular communication with sites to manage project expectations and issues
- Evaluate study-site practices for protocol quality, integrity, and regulatory adherence
- Escalate quality issues as appropriate
- Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution
- Support the study start-up phase when applicable
- Ensure site documents are available for Trial Master File filing
- Verify Investigator's Site File maintenance in accordance with GCP and local regulatory requirements
- Create and maintain site-management documentation, monitoring-visit findings, and action plans
- Submit visit reports and generate follow-up letters and other required study documentation
- Collaborate with study team members to support project execution
- Support development of project subject recruitment plans on a per-site basis when applicable
- Support site financial management and retrieve invoices according to local requirements when applicable
Requirements
What you’ll need- Bachelor's Degree in scientific discipline or health care preferred; marked as required in the posting
- At least 1.5 years of on-site monitoring experience
- Equivalent combination of education, training and experience may be accepted in lieu of degree
- Knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Therapeutic and protocol knowledge as provided in company training
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to use a laptop computer, iPhone, and iPad where applicable
- Written and verbal communication skills, including good command of English
- Organizational and problem-solving skills
- Time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Benefits
Comp & perks- Incentive plans, bonuses, and/or other forms of compensation may be offered
- Health and welfare benefits may be offered
- Other benefits may be offered
