Specialist, Study Training Compliance &… at Care Access · USA Remote

• Study Training Compliance
  • 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 documentation of training is complete, current, and meets ICH-GCP, SOP, and sponsor requirements.
• Delegation of Authority (DOA) Coordination
  • 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.
• eISF & Documentation Management
  • Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems.
  • Ensure that site staff training records are audit-ready and aligned with regulatory and sponsor expectations.
  • Support internal audits, monitoring visits, and sponsor document requests.
• General Support & Collaboration
  • 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 as appropriate to ensure study and site compliance timelines are met.
  • Communicate effectively with internal staff, sponsors, and vendors regarding compliance tasks and timelines.
  • Assist in problem-solving training, or access issues, contributing to solutions in collaboration with the broader team.
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

• 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.
• Knowledgeable in Microsoft Office applications, particularly Excel, Word, Outlook, and SharePoint; familiarity with internet-based research and database systems is essential.
• Strong interpersonal and customer service skills, with the ability to interact professionally with healthcare providers, internal staff, and external business partners.

Certifications/Licenses, Education, and Experience

• Minimum Education:
  • Bachelor’s degree in Life Sciences, Health Administration, or a related field preferred.
• Minimum Experience:
  • Minimum of 2 years of experience in a Central Support or clinical research support role at Care Access or within a comparable organization (in clinical research, training compliance, operations, or document management in a regulated environment).
  • 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.