Clinical Research Training Specialist

St. Luke's is proud of the skills, experience and compassion of its employees. The employees of St. Luke's are our most valuable asset! Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.

  

 

 

 

The Clinical Research Training Specialist supports the Clinical Research Quality Management System by developing, administering, coordinating, and evaluating education and training for investigators, clinical research personnel, and supporting departments. The position develops and administers role-based training requirements, training matrices, competency assessments, research readiness activities, and training documentation to promote compliance with applicable regulatory requirements, institutional policies and procedures and Good Clinical Practice (GCP) standards.

Working closely with the Manager of Clinical Research Quality, department leaders, and organizational learning partners, the specialist supports staff onboarding and ongoing professional development, co-chairs the Quality Management Committee, and translates regulatory and quality requirements into practical guidance and educational resources. The specialist applies principals of adult learning to develop clear, engaging, and effective educational content and learning experiences. The position uses training outcomes, quality findings, and performance metrics to identify learning needs and support continuous improvement across the clinical research enterprise.

The specialist collaborates with organizational learning and training partners to develop interactive and technology enabled educational approaches, as appropriate, to support knowledge retention, competency, and compliant research conduct.

JOB DUTIES AND RESPONSIBILITIES:

• Supports the clinical research Quality Management System and its compliance with federal, state, and local regulations, Good Clinical Practice (GCP), as well as institutional policies and procedures, including IRB and Network Compliance under the direction of the Manager of Clinical Research Quality. 
• Co-Chair the departmental Quality Management Committee in collaboration with the Manager of Clinical Research Quality, including planning and facilitating meetings and work sessions; developing agendas; coordinating the review approval, and implementation of policies, Standard Operating Procedures (SOPs), and training initiatives; tracking action items; presenting quality and training metrics; and communicating committee decisions and required follow-up.
• Translate complex regulatory requirements into practical operational guidance for research teams including training materials, tools, and educational resources related to clinical research regulations, institutional policies and procedures, and research best practices in alignment with Standard Operating Procedures (SOPs) that are compliant with all applicable regulations, policies, and Good Clinical Practices (GCP).
• Develop, implement, and maintain clinical research education and training programs on Good Clinical Practice (GCP), Human Subject Protection requirements, FDA regulations, institutional policies, Standard Operating Procedures (SOPs), and other applicable research requirements.
• Administer the clinical research training program and training matrix, including role-specific training, knowledge assessments, and competency checks to verify understanding, identify learning gaps, and promote consistent knowledge and compliant research conduct across study teams, investigators, and supporting departments.
• Develop and deliver education on investigator oversight, appropriate delegation of study responsibilities, documentation of delegated duties, and verification that study personnel are qualified and trained for assigned research activities.
• Support department management in onboarding and training clinical research personnel by providing role-specific learning plans, standardized training resources, regulatory guidance, and tools to assess training completion and competency. Collaborate with managers to identify learning needs and coordinate applicable education, maintain training documentation, and promote consistent preparation across clinical research roles.
• Coordinate the research-readiness process for investigators and clinical research personnel by confirming completion of institutional, regulatory, and role-specific training requirements, including overall training profiles, initial training, and ongoing compliance with institutional general and role-specific procedural qualifications and training.
• Deliver engaging live and virtual training sessions, workshops, and educational seminars tailored to roles and learning needs of clinical research personnel, investigators, and research support staff. Evaluate training effectiveness through learner feedback, knowledge assessments, competency results, participation and completion data, and identified quality or compliance trends. Use evaluation findings to refine educational content, delivery methods, and learning resources and to recommend targeted follow-up education or retraining, as appropriate.
• Maintain training records for investigators and clinical research personnel; collaborate with department leaders to identify retraining needs; and coordinate documentation of completed training.
• Collaborate with organizational learning partners to optimize learning technology, training assignments, completion tracking, reporting, and retention of compliance documentation.
• Develop, monitor and report training and quality metrics and key performance indicators (KPIs) through reports and dashboards provided to departmental leadership and the Quality Management Committee.
• Support audit and inspection readiness by conducting quality reviews of clinical research records and processes. Use review findings to identify learning needs and develop targeted education, guidance, or retraining.
• Coordinate and support technology, process, and quality improvement initiatives and projects based on quality findings, metrics, stakeholder feedback, and strategic priorities.
• Remain current with industry best practices and emerging trends in clinical research quality management.
• Maintains confidentiality of all materials handled within the Network/ Entity as well as the proper release of information.
• Complies with Network and departmental policies regarding issues of employee, patient and environmental safety and follows appropriate reporting requirements. 
• Demonstrates/models the Network’s Service Excellence Standards of Performance in interactions with all customers (internal and external).  
• Demonstrates Performance Improvement in the following areas as appropriate: Clinical Care/Outcomes, Customer/Service Improvement, Operational System/Process, and Safety.
• Demonstrates financial responsibility and accountability through the effective and efficient use of resources in daily procedures, processes and practices.
• Complies with Network and departmental policies regarding attendance and dress code. 

PHYSICAL AND SENSORY REQUIREMENTS:

Requires sitting for up to 7 hours per day, 5 hours at a time. Standing for up to 4 hours per

day, 3 hours at a time. Requires frequent fingering, handling, and twisting and turning. Occasionally requires lifting, carrying and pushing and pulling objects weighing up to 20

pounds. Occasionally requires reaching above shoulder level. Must have the ability to hear as it relates to normal conversation and seeing as it relates to general vision.

Employees who work in patient care areas where they may have potential exposure to patients with suspected or proven tuberculosis (TB) must have the ability to wear a particulate respirator and be fit-tested in compliance with the current recommendations from the CDC (enforced by OSHA) or must provide physician documentation as to the inability to wear a particulate respirator.

EDUCATION:

 

Bachelor’s degree in health sciences, life sciences, nursing, education, instructional design, healthcare administration, or a related field required. Master’s degree in a related field preferred.

 

Current clinical research certification, such as SOCRA CCRP, ACRP-CP, required.

 

TRAINING AND EXPERIENCE:

 

Minimum of five (5) years of progressively responsible clinical research experience in a research site, academic medical center, health system, or comparable research environment, including at least two (2) years of experience in clinical research education and training, quality management, regulatory compliance, or a related function.

Demonstrated experience developing, delivering, and evaluating adult education or workforce-training programs, including role-based education, curriculum development, competency assessment, and live and virtual facilitation.

 

Demonstrated knowledge of standard clinical research processes, research site operations, investigator responsibilities, and quality management practices.

 

Working knowledge of applicable FDA and HHS regulations, ICH Good Clinical Practice, and institutional and IRB requirements governing clinical research.

 

Experience supporting competency-based onboarding, continuing education, training matrices, learning management systems, training documentation, and retraining activities preferred.

 

Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, Teams, virtual training platforms, and learning management systems required.

 

Strong communication, facilitation, organizational, analytical, and problem-solving skills, with the ability to translate complex requirements into clear, practical education and guidance.

 

Proficiency with electronic regulatory systems, clinical trial management systems, learning management systems, and other research-related electronic systems.

Please complete your application using your full legal name and current home address.  Be sure to include employment history for the past seven (7) years, including your present employer.  Additionally, you are encouraged to upload a current resume, including all work history, education, and/or certifications and licenses, if applicable.  It is highly recommended that you create a profile at the conclusion of submitting your first application.  Thank you for your interest in St. Luke's!!

St. Luke's University Health Network is an Equal Opportunity Employer.