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Care Access · 1 day ago

Specialist, Study Training Compliance & DOA Management

United States

Full-time

Hybrid

Entry, Mid Level

2+ years exp

Care Access is dedicated to improving health access and research opportunities globally. They are seeking a Specialist in Study Training Compliance and DOA Management to support compliance functions across clinical research studies, ensuring staff readiness and regulatory adherence.

Clinical TrialsHealth Care

No H1B

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

Perform other duties as assigned

Qualification

Clinical research operationsTraining complianceDocumentation managementEISF familiarityMicrosoft Office proficiencyInterpersonal skillsOrganizational skillsCommunication skills

Required

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

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