Patient Enagement Lead

The Patient Engagement Lead will play a crucial role in enhancing patient engagement, enrollment, and satisfaction by leading training initiatives and quality assurance programs. This role focuses on developing and implementing training programs, maintaining adherence to regulatory standards, and ensuring a positive patient experience. The ideal candidate will have a strong background in clinical research, quality control, and patient engagement strategies.

DUTIES & RESPONSIBILITIES

• Drive training strategies and design programs for the Patient Enrollment team to ensure proficiency in tasks and duties.
• Train and coach the Patient Enrollment team on study-specific materials, disease processes, and quality standards.
• Develop and implement comprehensive training materials aligned with IRB guidelines.
• Work closely with the QA team to evaluate training effectiveness and drive continuous improvement.
• Ensure training programs align with Phase I-IV clinical trial protocols, FDA regulations, and ICH/GCP guidelines.
• Conduct onboarding and ongoing training sessions for new and existing team members.
• Collaborate with department leads to address training gaps and optimize learning initiatives.
• Lead performance assessments through knowledge checks, feedback sessions, and training reports.
• Develop and update SOPs, training manuals, and guides to reflect current regulations and organizational needs.
• Monitor and track the impact of training programs through scorecards and reports.
• Assist in the development and implementation of quality assurance programs to ensure compliance with SOPs, ICH GCP, FDA regulations, and IRB guidelines.
• Perform ongoing quality reviews of study documentation, ensuring adherence to protocol requirements.
• Conduct audits and prepare for internal and external regulatory inspections.
• Analyze trends in protocol deviations and quality findings to recommend corrective actions.
• Ensure source documentation accuracy and completeness, including amendments.
• Collaborate with stakeholders to implement quality improvement initiatives.
• Regularly audit call center operations to ensure patient communication meets quality standards.
• Provide reports and actionable insights based on QA findings.
• Ensure the documentation of patient interactions in compliance with HIPAA standards.
• Monitor and analyze patient engagement metrics to identify areas for improvement.
• Assist in development and execution strategies to enhance patient diversity in clinical trials.
• Provide support to the Patient Engagement team, fostering a culture of excellence.
• Assist with presentation of data and analytics of the training and QA initiatives
• Meet Department KPIs and ensure the team is set to achieve the goals set for the department
• Other tasks as assigned

KNOWLEDGE & EXPERIENCE

Education:

• Bachelors degree required; Masters degree preferred

Experience:

• 3+ Years of experience in clinical research or related healthcare field

Credentials:

• N/A

Knowledge and Skills:

• Sound knowledge of Clinical Research Protocols, and understanding of IRB/FDA regulations with GCP/ICH guidelines knowledge
• Ability to think analytically and critically to identify training needs and design training plans
• High typing speed (WPM) 50+ preferred
• Computer proficiency, especially in Word, Excel, Outlook, and Google Docs
• Excellent communication and customer service skills
• Outgoing personality
• Well-organized with attention to detail
• Must be able to multitask