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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 maintaining documentation and communication to ensure adherence to GCP and ICH guidelines.
Highest-signal resume keywords
Site MonitoringRegulatory ComplianceGCP KnowledgeProject ManagementClinical Research Experience
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 Monitoring VisitsProtocol AdministrationRegulatory SubmissionsCRF CompletionData Query ResolutionTrial Master File ManagementTherapeutic KnowledgeCRA Training Program CompletionMicrosoft WordMicrosoft Excel
Soft Skills
Written CommunicationVerbal CommunicationOrganizational SkillsProblem-Solving SkillsTime Management
Tools & Technologies
IPhoneIPadLaptop Computer
Industry Keywords
Clinical ResearchICH GuidelinesGCPSite ManagementSubject Recruitment
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Perform site monitoring visits, including selection, initiation, monitoring and close-out visits
- Work with sites to adapt, drive and track subject recruitment plans
- 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 where applicable
- Ensure site documents are available for Trial Master File filing
- Verify Investigator's Site File maintenance according to GCP, ICH 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 required study documentation
- Collaborate with study team members to support project execution
- Support development of project subject recruitment plans on a per-site basis where applicable
- Support site financial management and retrieve invoices according to local requirements where applicable
Requirements
What you’ll need- Bachelor's Degree in scientific discipline or health care preferred
- Equivalent combination of education, training and experience may be accepted in lieu of degree
- Some organizations require completion of CRA training program or prior monitoring experience
- Basic knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines
- Good 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
- Effective 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
