Clinical Training Specialist III (4326)

Clinical Training Specialist III is part of the Business Operations Department. The duties include working with all departments to determine what types of skills are important, designing methods to test how well employees are performing tasks, and developing improved training material based on the results.  

 

DUTIES & RESPONSIBILITIES

• Collaborates with the HR, Organizational Development, QACE, Site Operations and other teams to deliver training programs to site staff. 
• Delivers new hire clinical orientation to employees upon their completion of HR driven onboarding.
• Conducts ongoing training efforts for staff based on needs found in performance evaluations, career development plans, performance improvement plans and other plans set by management. 
• Creates and delivers ongoing training based on QC, QA and organization data/deviation trends as well as monitoring report trends.   
• Manages and coordinates Site DM training materials  
• Collaborates with members of the cross functional team to maintain, revise and update training material. 
• Collaborates with all departments to deliver standardized methods of clinical procedures across sites.  
• Participates in Clinical Training team and Business Operations meetings and continuing education.  
• Coordinates in-person mentoring for site employees based on Director, Business Operations requests.  
• Conducts and coordinates webinars for study-specific training, new initiatives, changes in protocols in collaboration with site management and Business Operations. 
• Liaises with the Clinical Training & Learning and Development Specialists. 
• Assists Site Operations in coordinating internal staff training sessions. 
• Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis. 
• Has a working knowledge of FDA regulations, GCP/ICH guidelines, clinic SOPs and individual protocols as required. 
• Works with the Business Operations leadership to identify training needs and organize training interventions to meet quality standards. 
• Performs other duties as assigned by management. 
• Manages QMD Training across Paycom LMS and Florence 
• Creates and updates training materials based on industry standards and as assigned by department leadership. 
• Collaborates with Site Operations, QACE, Regulatory, HR and other functional teams to ensure all staff completes mandatory training.

KNOWLEDGE & EXPERIENCE

Education:

• BA/BS in health, life sciences or similar field or four years of experience in clinical trials research setting may substitute Foreign Medical Doctor Degree Preferred

Experience:

•  Minimum two years of clinical trials research training and/or presentation experience  

Credentials:

• N/A

Knowledge and Skills:

• Comprehensive knowledge of and proficiency using electronic data capture systems and an ability to learn new software quickly  
• Proven ability to use sound judgment and diplomacy while interacting with staff and participating study sites  
• Ability to lead and teach cross-functional groups and site personnel  
• Proficiency in Google Workspace 
• Proficiency in LMS  
• Excellent written and oral communication skills  
• Strong interpersonal and collaboration skills 
• Ability to learn and adopt new software and programs to conduct duties and responsibilities

KPI & Success Metrics 

• Enroll new staff in Florence, CRIO, and CITI platforms within 2 business days of hiring. 
•  Assign required QMD curriculum to new employees within 2 business days of Paycom setup. 
• Produce professional CVs within 3 business days of receiving a completed CV Request Form. 
• New Required Trainings will be routed within 3 business days of DM Credentials creation 
• Coordinate QMD sign-offs for PRN staff within 5 business days of system access. 
• Launch CAPA-related Paycom modules within 2 business days of receiving the staff roster. 
• Provide monthly Paycom LMS reports to Department heads for tracking overdue training progress. 
• Audit and update the Paycom catalog annually to retire outdated training materials. 
• Maintain a minimum 85% completion rate for quarterly Paycom LMS course requirements. 
• Complete PRN training requests, including consultation and delivery, within 14 business days. 
• Develop Clinical training material as per guidance and deadlines established by Business Operations Leadership.