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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 processes, including regulatory submissions, compliance with ICH guidelines, and site activation strategies. Proven ability to manage documentation, mentor colleagues, and coordinate with various stakeholders to ensure project success.
Highest-signal resume keywords
Clinical Research ExperienceICH Guidelines KnowledgeRegulatory Submissions CoordinationSite Activation StrategyContract Negotiation
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 DevelopmentRegulatory ProcessesInvestigator Start-Up DocumentsResearch Protocol RequirementsQuality ReviewDocument ManagementBudget TrackingSubmission ComplianceEssential Study DocumentsAudit-Ready Documentation
Soft Skills
CommunicationMentoringProblem-SolvingTeam CollaborationAdaptability
Tools & Technologies
Computer Software
Certifications & Qualifications
University/College Degree in Life ScienceCertification in Allied Health Profession
Industry Keywords
IRBRegulatory AuthorityClinical TrialsINDsCTAsSOPsAudit ReadinessSite ContractsClinical ResearchFast-Paced Environment
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Serve as primary contact with investigative sites during study start-up and maintenance
- Collect, organize, quality-review, format, compile, and file investigator and essential study documents
- Coordinate EC/IRB/Third body/Regulatory Authority applications and submissions within agreed timelines
- Prepare country application forms, cover letters, and routine submissions such as INDs/CTAs
- Liaise with regulatory authorities, internal teams, external vendors, and investigative sites
- Review final submission documents and ensure compliance with regulations, ICH/GCP, SOPs, quality standards, budgets, and client expectations
- Track start-up, maintenance, site activation, contract, and budget activities and milestones
- Identify, prevent, and escalate study issues and risks to deliverables
- Maintain systems and documentation in an audit-ready state
- Participate in team and project meetings
- Assist with site activation strategy, projections, and timelines
- Review and customize country- and site-specific informed consent forms
- Support negotiation and tracking of site contracts and budgets when applicable
- Mentor and train new hires and less-experienced colleagues when suitable
- Perform other duties as assigned
Requirements
What you’ll need- Residing in the United States
- University/College degree in a relevant field (life science preferred), or certification in a related allied health profession from an appropriate accredited institution
- Relevant and equivalent experience may be considered in lieu of educational requirements
- Alternatively, High School Diploma or equivalent plus at least 2 years of clinical research experience
- Minimum 2 years of experience in clinical development or start-up/regulatory processes
- Strong working knowledge of ICH guidelines and RA, IRB/IEC, and other applicable regulations/guidelines
- Familiarity with investigator start-up documents and contract/budget negotiation processes
- Previous interaction with operational project teams and investigative sites
- Demonstrated understanding of research protocol requirements and ability to communicate/educate others about them
- Ability to work in a fast-paced, constantly changing, technology-based environment
- Ability to sit for extended periods and operate a vehicle safely
- Ability to perform repetitive hand movements and occasional crouching, stooping, bending, and twisting
- Ability to use various computer software
- Ability to lift/carry 15–20 lbs
- Regular and consistent attendance
- Varied hours may be required
Benefits
Comp & perks- Frequent travel to clients/site locations with occasional domestic and international travel
- Ongoing application acceptance