Principal Trainer, Clinical Education

Care Access

8h•Hybrid

About The Position

Care Access is seeking a highly experienced Principal Trainer, Clinical Education, to join our dynamic Clinical Education Team, part of the Global Expansion and Study Operations department. The Principal Trainer, Clinical Education plays a key role in the execution and continuous improvement of onboarding, upskilling, and competency development across clinical operations. Reporting to the Director of Clinical Education, this role is responsible for deploying standardized training frameworks, refining educational content, and supporting implementation across teams and functions. The Principal Trainer works cross-functionally to translate strategic training goals into actionable learning solutions and ensure that training programs are scalable, compliant, and aligned with Care Access's operational and quality standards. This role requires experience serving as Sub-investigators (Sub-I), having conducted physical examinations and being responsible for medical decision-making. The Principal Trainer, Clinical Education will have had prior experience in core site responsibilities such as protocol execution, participant safety oversight, source documentation, and Good Clinical Practice (GCP) compliance and applicable regulatory requirements. The Principal Trainer, Clinical Education will lead onboarding sessions and training initiatives primarily for PIs and Sub-Is, delivering a discussion peer-to-peer orientated approach. The Principal Trainer, Clinical Education will be able to demonstrate strong communication skills by engaging Physicians, Nurse Practitioners and Certified PAs in practical dialogue to ensure protocol clarity, regulatory understanding, and operational readiness. As needed, this role will also support structured training initiatives for CRCs and site staff to reinforce standardized processes and study requirements. The Principal Trainer, Clinical Education will support the Director, Clinical Education to develop and deliver Investigator level curriculum. The Principal Trainer, Clinical Education demonstrates clinical confidence, ability to think critically, and respond effectively in real time. They will build a rapport with Investigators while balancing and reinforcing exceptionally high standards of clinical study quality.

Requirements

Ability to independently lead multi-site training initiatives and mentor other trainers.
Strong understanding of clinical trial operations, site workflows, and regulatory landscapes.
Expertise in developing, delivering, and assessing adult education and competency-based programs.
Ability to collaborate across functions and communicate effectively with clinical, operational, and leadership teams.
Strategic planning and analytical skills to align training with organizational goals and measure impact.
Strong organizational skills with the ability to manage competing priorities in a fast-paced environment.
High proficiency in digital training tools and platforms.
Agility to adapt to evolving priorities, technologies, and site needs.
Excellent change management skills to support adoption of new systems and workflows.
Strong analytical skills to interpret training data and generate actionable insights.
Bachelor's degree in healthcare, life sciences, education, or a related field.
Registered Nurse Practitioner or Certified Physician Assistant with 4+ years in clinical research with at least 1 year in a leadership, strategic, or multi-site training role.
Demonstrated experience developing and delivering training for Investigators/Sub-Investigators, including investigator onboarding (in-person and/or virtual).
Proven expertise in site-based clinical trial operations.
Demonstrated leadership in instructional design, adult learning, and competency-based education.
Advanced skills in digital learning platforms, Learning Management Systems (LMS), and virtual collaboration tools (e.g., Microsoft Teams).
Exceptional communication, facilitation, and stakeholder engagement skills.

Nice To Haves

Bilingual or multilingual skills are a plus.
Advanced degree preferred.
Preferred certifications include RN, ACRP, or SOCRA

Responsibilities

Lead the revision, expansion, and optimization of onboarding materials and workflows to establish a standardized, role-specific, and site-relevant onboarding program.
Deliver hands-on, in-person onboarding and provide ongoing virtual support during the initial integration period and beyond, ensuring continuous guidance and reinforcement of learning.
Drive the development, review, and maintenance of documentation, training templates, study-specific training, and platform-specific user guides tailored to Care Access tools (e.g., ST, UPVIO, CRIO, IT Support and Supply Portal, Fusion Live, Safety Culture) and/or sponsor-provider platforms.
Conduct baseline assessments and early issue resolution for new hires.
Lead the creation, review, and refinement of training curricula, role-specific training plans, and educational materials, ensuring alignment with organizational standards, regulatory requirements, and evolving operational needs.
Collaborate with Subject Matter Experts (SMEs) and cross-functional teams to ensure educational content reflects current regulatory standards, organizational priorities, and clinical best practices.
Design and implement competency evaluation frameworks and assess clinical skills during onboarding and throughout training to ensure readiness and ongoing proficiency.
Serve as a primary resource for onboarding support, development planning, and performance improvement initiatives in collaboration with departmental Managers.
Facilitate targeted development sessions with individuals or groups and provide tailored resources to support performance growth and skill enhancement.
Monitor progress of supported staff and provide regular updates and recommendations to leadership (i.e., Regional Managers, Site Support Solutions, etc. and Director of Clinical Education).
Identify patterns in performance needs and proactively recommend scalable solutions to strengthen site and team effectiveness.
Lead train-the-trainer initiatives and mentorship programs to build internal training capacity and scalability across sites and teams.
Collaborate with internal departments launching workflows to ensure successful training implementation and supporting documentation.
Design and lead small-group or site-specific training sessions to ensure consistent understanding and adoption of Care Access systems and processes.
Develop advanced or supplemental training materials to enhance virtual training programs and align them with strategic priorities.
Collaborate and liaise with the Instructional Designers under the Clinical Education team for the review and input of new educational material.
Utilize LMS analytics and feedback tools to track learner engagement, knowledge retention, and training effectiveness, adjusting methods accordingly.
Support change management by developing targeted training to help staff adapt to new technologies, processes, and sponsor requirements.
Conduct and oversee regular clinical competency assessments to identify knowledge gaps and professional development needs.
Deliver compliance refreshers and ensure adherence to SOPs, WIs, and applicable regulatory frameworks.
Measure and report training effectiveness using feedback loops, performance metrics, audit trends, and CAPA data.
Lead the continuous improvement of training materials and delivery methods informed by data, operational insights, and staff feedback.
Develop and lead audit preparedness workshops and mock audit simulations to strengthen regulatory readiness.
Act as a key educational resource for Principal Investigators (PIs), Sub-Investigators (Sub-Is), and clinical leaders by providing comprehensive strategic training support.
Guide investigators on applying training to protocol execution, regulatory compliance, and Care Access processes.
Support orientation of new investigators and clinical leaders and ensure seamless integration into Care Access’s quality and training expectations.
Collaborate with leadership to assess knowledge gaps, support adherence, and promote a culture of continuous learning and compliance.
Maintain strong engagement and training effectiveness through proactive follow-ups and customized educational strategies.
Develop tailored investigator leadership training modules focused on decision-making, risk management, and oversight of clinical teams.
Collaborate with Quality and Regulatory teams to align training programs with audit findings, evolving GCP standards, and FDA/EMA guidance.
Analyse site performance data, audit outcomes, and feedback to identify training gaps and propose system-wide improvements.
Provide quarterly impact reports to leadership.
Develop crisis-response training modules (e.g., handling protocol deviations, site closures, or safety events) to strengthen workforce resilience.
Perform other duties as assigned.