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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in coordinating clinical trial start-up activities, ensuring compliance with GCP and regulatory requirements, and effectively collaborating with cross-functional teams. Proficient in managing documentation and submissions to facilitate efficient trial initiation and site activation.
Highest-signal resume keywords
Clinical Trial CoordinationRegulatory ComplianceGCP KnowledgeSite Activation ManagementProcess Improvement
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Document ReviewInformed Consent Form CustomizationSite Feasibility TrackingSubmission Information ManagementClinical Trial Insurance CoordinationEssential Document ReviewSSU Data TrackingSubmission PreparationSite Contract ManagementTrial Master File Maintenance
Soft Skills
Excellent Communication SkillsProblem-Solving AbilityFlexibilityCollaborationIndependence
Tools & Technologies
JVRIMCTISClinical Trial Management Systems
Industry Keywords
Clinical ResearchPharmaceutical IndustryGlobal Clinical TrialsEthics CommitteeCompetent Authority
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Coordinate and track site feasibility activities
- Ensure confidentiality agreements are in place
- Collect and maintain regulatory, Competent Authority, and Ethics Committee submission information in JVRIM, CTIS, and similar systems
- Ensure clinical trial insurance is in place for submission
- Coordinate translations of submission documents
- Create, review, and customize country- and site-specific Informed Consent Forms
- Secure authorization of regulatory documents and contracts with relevant teams and vendors
- Collect and review initial regulatory packets and site contracts
- Coordinate site activation activities, regulatory and ethics approvals, and essential-document review for IP release
- Prepare ongoing submissions, amendments, periodic notifications, and safety notifications
- Ensure relevant documents are submitted to the Trial Master File
- Liaise with CRAs, CTMs, contract vendors, and Regulatory Leads to enable rapid trial start-up
- Inform team members when regulatory and contractual documents are completed
- Attend cross-functional project meetings and provide updates
- Identify, resolve, and escalate site issues and risks
- Review and provide feedback on site performance metrics
- Maintain accurate SSU data tracking entries
- Facilitate process improvement efforts
- Support development of start-up plans and essential document checklists
- Collaborate with regulatory, legal, and clinical operations teams to ensure compliant and efficient trial initiation
- Complete required training, timesheets, and expense reports accurately and on time
- Maintain knowledge of and comply with Parexel processes, ICH-GCPs, and applicable requirements
- Help investigator sites prepare to start clinical trials and reduce site activation timelines
Requirements
What you’ll need- Bachelor's degree or 3 years' clinical research or other relevant experience, or an equivalent combination of education, training, and experience
- Pharmaceutical or related industry experience
- Previous experience working in a start-up team, as a Clinical Trial Specialist, or in a similar role, having worked on global clinical trials
- Excellent knowledge of GCP and regulations
- Ability to work independently in a fast-paced environment
- Ability to identify and resolve site issues independently and escalate complex problems effectively
- Flexibility and willingness to support process improvement efforts
- Excellent verbal and written communication skills
- Ability to collaborate effectively with regulatory, legal, and clinical operations teams
- Experience with in-house trials or process design preferred
Benefits
Comp & perks- Premium salary
- Attractive benefits
- Medical care plan: Health, Dental & Vision
- Life Assurance
- Excellent work environment
- Culture of teamwork and collaboration
- People who motivate and face challenges together
- Innovative technology
- Excellent training
- Paid time off
- Health insurance
- Additional benefit offerings in accordance with applicable plans
- Potential eligibility for additional incentives, bonuses, or other compensation programs