Specialist, Study Training Compliance & DOA Management

Care Access

1d•Remote

About The Position

Care Access is seeking a skilled and experienced Specialist, Study Training Compliance and DOA Matrix Management, to join our dynamic Central Support Operations team, part of the Global Expansion and Study Operations department. The Specialist, Study Training Compliance and DOA Matrix Management within Central Support Operations team supports critical compliance functions to ensure study training requirements and delegation matrices are accurately managed across clinical research studies. This role contributes to site staff readiness and regulatory adherence by tracking training completion, maintaining essential clinical staff records, and ensuring Delegation of Authority (DOA) matrices are complete, reviewed, and approved in accordance with standard processes. The ideal candidate is organized, responsive, and passionate about maintaining quality in a regulated, fast-paced environment.

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, with the ability to interact professionally with healthcare providers, internal staff, and external business partners.
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 (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.

Nice To Haves

Familiarity with eISF (Florence) and clinical training platforms is a plus.

Responsibilities

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.