The QD Training and Development Associate I is responsible for providing oversight of Q-Ricculum, the research education and training program under the leadership of the Director of Compliance and Clinical Operations and the Director of Regulatory and Compliance. This includes development and management of the Q-Ricculum curriculum, overseeing its implementation and assessing outcomes related to training and education; identifying training and development needs and driving suitable training initiatives, working across ST to ensure employee success, such as development of personnel- and role-specific focused trainings; creating a training program for medical personnel and others in the field to support the organizational mission of ST and the creation and review of clinical research study source documents to be used at the site. This position is a hybrid, working remotely but reporting on site to the various sites, depending on organizational needs and training program requirements on an as needed basis.

DUTIES & ESSENTIAL JOB FUNCTIONS

Reporting to the Director of Compliance and Clinical Operations and Director of Regulatory and Compliance

· Development and management of Q-Ricculum, the research education and training program to address employee training needs, including regular assessment of training effectiveness through post-training quizzes and assessments after training and return on investment in the training program on a quarterly basis.

· Trains staff on policies, Standard Operating Procedures (SOPs), Guidance documents, Work Instructions (WI).

· Trains and develops staff to ensure operational objectives for ST conform to all relevant federal and state laws, regulations, guidelines; clinical research protocols, internal SOPs and WIs.

· Develops educational metrics to be reported to Executive Leadership on a quarterly basis.

· Provides opportunities for ongoing training development in person, written and remotely.

·Resolves any training-specific problems; Creates study-specific and personnel specific programs to align with the scope of the Research Training Program SOP.

· Maintains a clear understanding of research education training trends, developments and best practices to assist with ensuring low employee turnover and high retention and study demands to align the training program and strategy. e

· Development of yearly educational goals aligning with Quality Department and ST goals.

· Creation and review of source documents

· Performs other study or educational-related duties as assigned.

In collaboration with Human Resources (HR)

· Coordinates all aspects of general employee onboarding, research-specific training and professional development.

· Ensures new hire orientation and training orientation is adequately documented.

· Interfaces with all departments to collaborate on training needs to ensure standardization across ST.

· Identifies and assesses future and current training needs through discussions with supervisors.

· Develop and implement systems for gauging employee satisfaction and developing leaders in ST.

· Performs other related duties as assigned.

Interaction with Quality Department

· Stays current on all Federal and State regulations.

· Assists with drafting and updating policies, SOPs, Guidance documents and WI; participates in annual SOP review.

· Participates in developing Corrective and Preventive Action plans, including training related to findings.

· Trains and develops staff to ensure operational objectives for the organization are in conformance to all relevant Federal and State laws, regulations, guidelines, clinical research project and trial protocols, internal SOPs and WIs.

· Performs other related duties as assigned.

OTHER SKILLS AND ABILITIES:

· Exceptional attention to detail.

· Strategic thinker and self-starter

· Familiarity with traditional and modern training methods, tools and techniques

· Familiarity with talent management and succession planning

· Ability to conduct a cost-benefit analysis and calculate training ROI.

· Sound decision-making and organizational skills.

· Ability to present complex information to a variety of audiences in person, through the written word and virtually.

· Able to successfully complete complex tasks accurately and quickly, despite frequent interruptions.

· Displays excellent organizational and planning skills, including the ability to develop effective systems.

· Balances tasks with competing priorities effectively with little direction.

· Able to work independently with limited feedback.

· Functions well in high-pressure situations, including managing tight and changing timelines.

· Possesses and exhibits highly effective verbal and written communication skills demonstrated through positive interactions with coworkers, managers, clients, vendors, industry experts and others.

· Models team collaboration skills by working effectively with others to accomplish goals.

· Independently displays a passion for learning and development.

· Maintains knowledge of industry developments through self-guided individual training.

· Able to manage sensitive information with confidentiality.

· Solicits & responds positively to direction & constructive criticism from supervisors, managers, & peers.

REQUIREMENTS:

· Bachelor’s Degree required, preferably in the biopharmaceutical/healthcare industry or related field.

· Minimum five (5) years’ experience working in Clinical Research or a related field.

· Knowledge of industry regulations, including but not limited to HIPAA, OSHA, GCP, GDP, CFR and ICH Guidelines

· Proficiency in English required. Proficiency in Spanish preferred.

· Proficiency with Microsoft Office suite and patient database software, Electronic Data Capture (EDC).

Job Type: Full-time

Pay: Up to $70,000.00 per year

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to Relocate:

• North Miami, FL: Relocate before starting work (Required)

Work Location: In person