Specialist, Study Training Compliance & DOA Management
C
Care AccessClinical Research
USA RemoteFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- Minimum of 2 years
- Required Skills
- SharePointMicrosoft ExcelMicrosoft Office
Requirements
- 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.
- 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.
Responsibilities
- 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.
- 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 that 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 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.
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