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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 operations, compliance documentation, and training management, ensuring alignment with regulatory standards and sponsor expectations. Proficient in utilizing technology platforms for tracking and maintaining training records while fostering effective communication across cross-functional teams.
Highest-signal resume keywords
Clinical Research OperationsTraining Compliance ManagementRegulatory DocumentationMicrosoft Office ProficiencyInterpersonal Communication 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
Training Documentation ManagementCompliance TrackingOnboarding SupportMulti-Trial Documentation WorkflowsEISF FamiliarityDatabase Systems KnowledgeDetail-Oriented OrganizationTechnology Platform UtilizationStudy-Specific TrainingAudit-Ready Record Maintenance
Soft Skills
Strong Interpersonal SkillsCustomer Service SkillsAdaptabilityCollaborationProblem-Solving
Tools & Technologies
Clinical ConductorFlorenceSIPMicrosoft ExcelMicrosoft WordMicrosoft OutlookMicrosoft SharePointEISF Systems
Industry Keywords
ICH-GCPSOPCompliance StandardsClinical Training PlatformsHealth AdministrationLife Sciences
About the role
Key responsibilities & impact- Track and monitor clinical staff training completion, including study-specific and mandatory compliance training
- Support delegation processes during study start-up by verifying that training aligns with assigned roles
- Ensure training documentation is complete, current, and meets ICH-GCP, SOP, and sponsor requirements
- Support DOA matrix setup and maintenance by confirming training completion and role assignments
- Work cross-functionally to ensure delegation readiness for protocol activities and study transitions
- Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems
- Ensure site staff training records are audit-ready and aligned with regulatory and sponsor expectations
- Support internal audits, monitoring visits, and sponsor document requests
- Collaborate with internal stakeholders to support study training and access coordination across study phases
- Participate in team meetings and contribute to documentation and communication tools to enhance team efficiency
- Escalate issues or delays to senior team members to ensure study and site compliance timelines are met
- Communicate with internal staff, sponsors, and vendors regarding compliance tasks and timelines
- Assist in resolving training or access issues with the broader team
- Perform other duties as assigned
Requirements
What you’ll need- Understanding of clinical research operations and the importance of compliance and documentation
- Strong organizational and tracking skills; detail-oriented with the ability to manage multiple tasks effectively
- Comfortable working with technology platforms (e.g., Clinical Conductor, Florence, SIP)
- Microsoft Office proficiency required
- Strong interpersonal and communication skills for cross-functional teamwork
- Ability to work both independently and as part of a collaborative team
- Professional and adaptable when interacting with providers, vendors, and sponsor representatives
- Knowledge of Microsoft Office applications, particularly Excel, Word, Outlook, and SharePoint
- Familiarity with internet-based research and database systems
- Strong interpersonal and customer service skills
- Bachelor's degree in Life Sciences, Health Administration, or a related field preferred
- Minimum of 2 years of experience in a Central Support or clinical research support role at Care Access or within a comparable organization
- Proven experience supporting onboarding, training compliance, and/or access coordination in a regulated research environment
- Demonstrated ability to navigate and work within compliance-driven systems and support multi-trial documentation workflows
- Familiarity with eISF (Florence) and clinical training platforms is a plus
- Must be able to work remotely within the United States
- Care Access is unable to sponsor work visas at this time
Benefits
Comp & perks- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
