The Specialist ensures compliance in clinical trials by tracking staff training, managing Delegation of Authority matrices, and maintaining documentation in a regulated environment.
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 requirements. Occasional planned travel may be required as part of the role.
What You Bring
Knowledge, Skills, and Abilities:
-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, Education, and Experience:
-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.
-Familiarity with eISF (Florence) and clinical training platforms is a plus.
Benefits (US Full-Time Employees Only):
-PTO/vacation days, sick days, holidays.
-100% paid medical, dental, and vision Insurance.
-75% for dependents.
-HSA plan Short-term disability, long-term disability, and life Insurance.
-Culture of growth and equality 401k retirement plan
Diversity & Inclusion:
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to 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 value diversity and believe that unique contributions drive our success.
At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients. Our team of experts is paving the way to take this vision forward through innovation and a unique technology-enabled.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to 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.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Top Skills
Clinical Conductor
Eisf
Florence
MS Office
Sip
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