Senior Specialist, Study Training Compliance & DoA Matrix Management

Care Access; Boston (MA); Remoto; USD 60.000 - 80.000; Tempo pieno

Vantaggi offerti da questo lavoro

PTO

Company paid holidays

Health insurance

Health Savings Account

Descrizione del lavoro

Care Access in the United States is seeking a Senior Specialist to manage study training compliance and DOA matrix workflows within the Central Support Operations team. You will coordinate training records, ensure ICH-GCP and sponsor requirements, and support audits with cross-functional partners across multiple studies.

The role emphasizes meticulous documentation, familiarity with Florence eISF and CTMS, and proactive collaboration to keep training and DOA readiness on track in a regulated

Competenze

• Bachelor’s degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred.
• Minimum of 3–5 years of experience in a Central Support, Clinical Operations, or Clinical Research Compliance role, ideally within a regulated research environment.
• Proven success supporting or leading training compliance workflows, DOA matrix coordination, and documentation management across multiple clinical studies.
• Demonstrated ability to work within quality-driven systems and maintain audit-ready documentation across multiple trials.

Mansioni

• Monitor and manage clinical staff training completion across multiple studies, ensuring alignment with study-specific and mandatory compliance requirements.
• Verify training accuracy and appropriateness for assigned roles during study start-up and transition phases.
• Ensure training records are consistently complete, current, and compliant with ICH-GCP, SOPs, and sponsor documentation standards.
• Lead coordination of DOA matrix setup, review, and updates in alignment with protocol milestones.
• Upload, maintain, and review essential staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems.

Conoscenze

Clinical research operations

Training documentation

Regulatory environment

Attention to detail

Cross-functional collaboration

Microsoft Office

Formazione

Bachelor’s degree in Life Sciences

Strumenti

Florence eISF

CTMS

Sponsor portals

Descrizione del lavoro

Senior Specialist, Study Training Compliance & DoA Matrix Management

USA Remote

About Care Access

Care Access is working to make the future of health better for all.With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care.We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need,and contribute to the medical breakthroughs of tomorrow.

With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.

Care Access is seeking a skilled and experienced Senior 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.

This role plays a critical function in overseeing the coordination and execution of training compliance and delegation documentation across a portfolio of clinical research studies. The Senior Specialist ensures alignment with regulatory standards and sponsor expectations by tracking training completion, maintaining site staff study-training records, and driving the timely review and approval of Delegation of Authority (DOA) matrices.

As a senior-level contributor, supports cross-functional partners, resolves complex documentation and compliance challenges, and contributes to process improvements that enhance operational efficiency. The ideal candidate brings a strong foundation in clinical research operations, deep familiarity with training workflows and delegation processes, and a commitment to documentation integrity in a fast-paced, regulated environment.

How You'll Make An Impact

• Study Training Compliance
  • Monitor and manage clinical staff training completion across multiple studies, ensuring alignment with study-specific and mandatory compliance requirements.
  • Verify training accuracy and appropriateness for assigned roles during study start-up and transition phases.
  • Ensure training records are consistently complete, current, and compliant with ICH-GCP, SOPs, and sponsor documentation standards.
  • Provide guidance to internal teams and site staff on training requirements and timelines.
• Delegation of Authority (DOA) Matrix Coordination
  • Lead coordination of DOA matrix setup, review, and updates in alignment with protocol milestones.
  • Confirm training compliance and role alignment for delegated tasks; flag gaps for resolution before study activation.
  • Serve as a point of contact for delegation matrix-related documentation during audits and monitoring visits.
• eISF & Documentation Oversight
  • Upload, maintain, and review essential staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems.
  • Ensure audit-readiness of all training and delegation matrix documentation across assigned studies.
  • Prepare for and support internal audits, sponsor inspections, and document request responses related to study training compliance.
• Cross-Functional Support & Collaboration
  • Collaborate with clinical teams and other internal stakeholders to ensure training and delegation readiness across all phases of study execution.
  • Contribute to study-specific training plans and compliance tracking tools to improve visibility and standardization.
  • Communicate proactively with internal staff, sponsors, and vendors to support compliance activities and elevate issues when necessary.
  • Participate in meetings and provide subject matter input on training and DOA compliance operations.
  • Identify and contribute to process improvement opportunities related to training workflows and delegation management.
  • Assist with the creation and refinement of guidance materials, trackers, and internal SOPs.
• 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

• Strong understanding of clinical research operations, training documentation, and the regulatory environment.
• Advanced organizational and tracking skills with attention to detail and documentation accuracy.
• Ability to manage multiple complex assignments with minimal oversight while meeting deadlines in a fast-paced setting.
• Comfortable navigating and maintaining documentation across platforms such as Florence (eISF), Clinical Conductor, and other training systems.
• Excellent communication and interpersonal skills; able to coordinate effectively with internal teams, site staff, vendors, and sponsors.
• Skilled in identifying and addressing gaps in training documentation or delegation readiness.
• Proficient in Microsoft Office (Excel, Word, Outlook, SharePoint); experience with compliance tracking databases and tools.

Certifications/Licenses, Education, and Experience

• Bachelor’s degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred.
• Minimum of 3–5 years of experience in a Central Support, Clinical Operations, or Clinical Research Compliance role, ideally within a regulated research environment.
• Proven success supporting or leading training compliance workflows, DOA matrix coordination, and documentation management across multiple clinical studies.
• Demonstrated ability to work within quality-driven systems and maintain audit-ready documentation across multiple trials.
• Familiarity with eISF systems (Florence), CTMS tools, and sponsor portals is strongly preferred.

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 $60,000 - $80,000 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.

Diversity & Inclusion

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.