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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 and regulatory compliance within clinical research, with strong skills in Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Proficient in managing site documentation, recruitment plans, and effective communication with study teams and sites.
Highest-signal resume keywords
On-Site Monitoring ExperienceGood Clinical Practice (GCP)Regulatory Requirements KnowledgeMicrosoft Office ProficiencyOrganizational Skills
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 AdministrationData-Query GenerationCRF CompletionTrial Master File ManagementStudy Documentation CreationSubject Recruitment PlanningFinancial ManagementProblem-Solving
Soft Skills
Written CommunicationVerbal CommunicationTime ManagementRelationship BuildingOrganizational Skills
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointLaptop ComputerIPhoneIPad
Industry Keywords
Clinical ResearchGood Clinical Practice (GCP)International Conference on Harmonization (ICH)Regulatory AdherenceStudy Protocol Knowledge
About the role
Key responsibilities & impact- Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
- Work with sites to adapt, drive, and track subject recruitment plans in line with project needs.
- Administer protocol and related study training to assigned sites and establish regular communication with sites.
- Evaluate study-site practices for proper protocol conduct and regulatory adherence; escalate quality issues.
- Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data-query generation and resolution; may support study start-up.
- Ensure site documents are available for Trial Master File filing and verify Investigator's Site File maintenance.
- Create and maintain site-management documentation, monitoring-visit findings, action plans, visit reports, follow-up letters, and other study documentation.
- Collaborate with study team members to support project execution.
- Support development of project subject-recruitment plans on a per-site basis, if applicable.
- Support site financial management and retrieve invoices according to local requirements, if applicable.
Requirements
What you’ll need- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Requires at least 1 of year of on-site monitoring experience. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
- Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
- Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good therapeutic and protocol knowledge as provided in company training.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
- Written and verbal communication skills including good command of English language.
- Organizational and problem-solving skills.
- Effective time and financial management skills.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Not eligible for UK visa sponsorship.