"Senior Training Specialist"

Overview

In collaboration with the Director of Quality and Education and reporting to the Quality and Education Manager, the Senior Training Specialist supports the growth and development of the Yale Cancer Center Clinical Trials Office (CTO) and Clinical Research Support Laboratory (CRSL) by achieving strategic objectives through the management and delivery of training and education programs for clinical research staff. This role supports both education and quality initiatives, with a focus on training and education. The Senior Training Specialist plays a crucial role in planning, developing, and implementing new training strategies in partnership with the leadership team, while maintaining compliance with federal and local regulations, including the FDA and IRB.

A significant aspect of this role is ensuring the quality of education provided, working closely with leadership to identify areas for process improvement and ensure the training programs remain efficient and impactful. The Senior Training Specialist coordinates with Yale University, YCC CTO Leadership, and other departments to address cross-functional training needs and ensure consistency in curriculum offerings. They are also responsible for compiling, managing, and updating training materials, ensuring these resources are easily accessible and current.

As part of supporting the training programs, the Senior Training Specialist continuously identifies and addresses educational gaps or re-training needs, especially those identified through audits, external reviews, or performance management assessments. They serve as a point of contact for staff inquiries about training concepts and procedures, providing ongoing support and resources.

The role also involves managing training compliance by monitoring and documenting staff understanding and competency. They play a key role in preparing and managing clinical research policies, SOPs, and other training documents, making sure they are up-to-date and easily navigated by staff.

This role may support quality initiatives such as evaluating clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and ICH Good Clinical Practice.

May review medical records of study participants, determine the impact of non-compliance (e.g. violations of federal regulations, GCP and University policies) on study plans/processes, makes judgments and communicates findings to investigators. Exercises judgment in the assessment of the level of risk associated with findings in terms of the need for reporting out to other regulatory entities. Supports regulatory inspections and audits.

Overall, the Senior Training Specialist is instrumental in advancing the educational and quality programs within the Yale Cancer Center, supporting the mission to uphold the highest standards of research and clinical practice. Other job duties as assigned.

*Please note: "Essential Duties" listed below are generic in nature and some duties may not be related to this position’s responsibilities. Please refer to this Position Focus for a more detailed review of the responsibilities of this role.

Essential Duties

1. Oversees the advancement and growth of the program. Gives direction and leadership supporting the philosophy, mission, strategy, and annual goals and objectives. Assumes primary accountability for disseminating and publishing all program information to create public awareness and support of the program.
2. Works closely with leadership, internal and external colleagues, and community residents to further develop and implement strategic plans.
3. Identifies, solicits, and cultivates community partnerships and collaborations to assist in the development and growth of the program. Develops the metrics to identify and measure the success of the program. Responsible for measurements of grant success and related evaluation.
4. Assists in identifying and evaluating potential future funding sources and contributes to the submission of grants and contracts supporting the program, including the annual submission and writing of all content areas and budgetary sections of grant applications. Develops and manages the program’s operating budget.
5. Develops the administrative infrastructure of the program. Manages human resource and administrative functions of the program, including staffing and hiring, supervision, performance development, counseling and discipline, if warranted. Oversees and manages information systems, facilities, and space needs.
6. Investigates, identifies, implements, and oversees the maintenance of systems to gather, track, and report information to support the initiatives of the program. Tracks all program activities and regularly informs leadership of progress on each initiative. Recommends structural or programmatic adjustments, changes or additions based on full knowledge of missions, goals, and objectives.
7. Initiates, designs, and manages the compilation of program communications, identifying outreach potential and promoting philanthropic and collaborative support of the program. Contributes to the development and assists in the management of content on the program’s website and monitors all changes and additions to the editorial content.
8. Performs other duties as assigned.

Required Skills and Abilities

1. Ability to establish and leverage broad networks and build collaborative relationships and professionalism, maturity, good judgment, and ability to work with confidential material and protected health information. Excellent interpersonal, presentation, verbal and written communication skills.
2. Ability to identify target audiences and create educational programs and content that engage, inform and motivate.
3. Strong analytical skills and data-driven thinking with an ability to work with, co-create, and track organizational metrics relative to educational programs and training.
4. Ability to work on quality and performance improvement processes and initiatives.
5. Ability to remain current with latest trends and best practices in the clinical trials operations, clinical trial regulatory compliance, and cancer research. Demonstrable understanding of clinical research processes and procedures from study start-up to study close out.

Preferred Education, Experience and Skills:

Three years minimum experience in area of research specialty, five years preferred. Must have experience working in oncology therapeutic research.

Preferred Licenses or Certifications:

ACRP/SoCRA (or equivalent) certification preferred.
 Master’s Degree in related field.

Principal Responsibilities

1. Develops and coordinates training and education for all YCC CTO employees including onboarding for all new employees to the CTO, ensuring consistency with curriculum offerings and working in conjunction with Yale School of Medicine, YCC CTO Leadership, and other Yale constituents. 
2. Plans, develops, implements, and evaluates education programs based on assessment of learning needs (orientation, in-service education, and continuing education). 
3. Implements a secondary check method to ensure new staff thoroughly understand the concepts presented to them as part of the onboarding process, and under the direction of the Assistant Director of Quality and Education ensures educational objectives are met during and following designated probationary period for CTO staff members. 
4. Identifies new training and development program methodologies and makes recommendations for implementation of those that support enhanced organizational effectiveness in this area. 
5. Implements and maintains a tracking system to ensure initial and ongoing job competency evaluations have been completed for all CTO staff. 
6. In partnership with Assistant Director of Quality and Education, coordinates regularly occurring training in-services with staff; works directly with the Smilow Cancer Hospital Director of Education, CTO research staff, managers and subject matter experts to schedule required training meetings for CTO staff. 
7. Ensures CTO staff compliance with all required training and education, reporting noncompliance to CTO leadership. 
8. Assists leadership if re-training is requested and prepares required training material. This may include but is not limited to (a) presentations which reflect quality assurance needs identified in audits, external reviews, and other assessments, and (b) remediation of individual employee educational needs based on performance management. 
9. Compiles and manages job aides, presentations, and other training materials into a repository easily accessible by staff; regularly updates all training documents as revisions and updates become available. 
10. Works with Assistant Director of Quality and Education and other CTO leaders to regularly assess training gaps in the CTO and evaluates training and education offerings with an end goal of maintaining a relevant, efficient, and robust training and education program. 
11. Tracks and documents available training. Manages these documents in a way that allows for easy navigation by staff. 
12. May be involved in centralized activities such as audit preparations and preparations of clinical research policies and standard operating procedures, as requested. 
13. Other job duties as assigned. 

Required Education and Experience

Bachelor’s Degree in degree in a health-related discipline, or other related field, experience working in oncology therapeutic research and a minimum 5 years experience working in a clinical research environment or in a prior training and education role, or an equivalent combination of education and related experience.