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Specialist, Study Training Compliance & DoA Matrix Management
Care AccessRemote, US, United StatesRemotefull_timeVerifiedPosted 4 Sept 2025
About the role
What We Do: Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. Who We Are: 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. We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.
Position Overview 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.
What You'll Be Working On Duties include but are not limited to:
Primary Duties and Essential Functions
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.
Other Responsibilities 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.
Scope of Role Autonomy of Role: Work is performed under general supervision Direct Reports: No Number of Direct Reports (if applicable): N/A Role(s) Managing: N/A
Physical Requirements This role requires 100% of work to be performed in a remote office environment and requires the ability to use keyboards and other computer equipment.
Travel Requirements This is a remote position with less than 10% travel requi
Position Overview 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.
What You'll Be Working On Duties include but are not limited to:
Primary Duties and Essential Functions
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.
Other Responsibilities 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.
Scope of Role Autonomy of Role: Work is performed under general supervision Direct Reports: No Number of Direct Reports (if applicable): N/A Role(s) Managing: N/A
Physical Requirements This role requires 100% of work to be performed in a remote office environment and requires the ability to use keyboards and other computer equipment.
Travel Requirements This is a remote position with less than 10% travel requi
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