Specialist, Study Training Compliance & DoA Matrix Management

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.

How You'll Make An Impact

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.

The Expertise 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.

Certifications/Licenses, Education, and Experience

Minimum Education:

Bachelor’s degree in Life Sciences, Health Administration, or a related field preferred.

Minimum Experience:

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.

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

How We Work Together

Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.

Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.

Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.

The expected pay range for this role is $50,000 - $70,000 USD per year for full time team members.

Benefits & Perks (US Full Time Employees)

Paid Time Off (PTO) and Company Paid Holidays

100% Employer paid medical, dental, and vision insurance plan options

Health Savings Account and Flexible Spending Accounts

Bi-weekly HSA employer contribution

Company paid Short-Term Disability and Long-Term Disability

401(k) Retirement Plan, with Company Match

Mandatory Employer Disclosures

Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.

Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.

Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.

Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.

Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.

#LI-Remote