Specialist, Study Training Compliance & DoA Matrix Management

Care Access

6d•$50,000 - $70,000•Remote

About The Position

Care Access is seeking a Specialist, Study Training Compliance and DOA Matrix Management to join its Central Support Operations team within the Global Expansion and Study Operations department. The role supports compliance across clinical research studies by tracking study and mandatory training, maintaining clinical staff records, and ensuring Delegation of Authority (DOA) matrices are complete, reviewed, and approved. It helps ensure site staff readiness and adherence to regulatory, standard operating procedure, and sponsor requirements. The specialist supports training and delegation processes during study start-up and throughout study phases, maintains essential staff training records and documents in eISF and associated systems, and helps keep records audit-ready. The role also supports audits, monitoring visits, and sponsor document requests; coordinates study training and access; communicates with internal staff, sponsors, and vendors; and escalates issues or delays as needed. This is a remote position within the United States, with 100% of work performed in a remote office environment and less than 10% travel. The expected pay range is $50,000–$70,000 USD per year for full-time team members.

Requirements

At least 2 years of experience in a Central Support or clinical research support role at Care Access or a comparable organization, in clinical research, training compliance, operations, or document management in a regulated environment.
Experience supporting onboarding, training compliance, and/or access coordination in a regulated research environment.
Ability to navigate compliance-driven systems and support multi-trial documentation workflows.
Understanding of clinical research operations and the importance of compliance and documentation.
Strong organizational and tracking skills, attention to detail, and ability to manage multiple tasks effectively.
Comfort using technology platforms; Microsoft Office proficiency is required.
Knowledge of Microsoft Office applications, particularly Excel, Word, Outlook, and SharePoint.
Familiarity with internet-based research and database systems.
Strong interpersonal, communication, and customer service skills for professional interaction with healthcare providers, internal staff, vendors, sponsors, and external business partners.
Ability to work independently and collaboratively.
Professional and adaptable when interacting with providers, vendors, and sponsor representatives.
Ability to use keyboards and other computer equipment.

Nice To Haves

Bachelor’s degree in Life Sciences, Health Administration, or a related field is preferred.
Familiarity with eISF (Florence) and clinical training platforms.
Experience with platforms such as Clinical Conductor, Florence, or SIP.

Responsibilities

Track and monitor clinical staff completion of 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.
Coordinate 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 on study training and access coordination across study phases.
Participate in team meetings and contribute to documentation and communication tools that enhance team efficiency.
Escalate issues or delays to senior team members to help meet study and site compliance timelines.
Communicate with internal staff, sponsors, and vendors about compliance tasks and timelines.
Help resolve training or access issues in collaboration with the broader team.
Perform other duties as assigned.