SUMMARY:  

The Quality and Training Operations Analyst plays a critical role in ensuring clinical trial sites operate efficiently, meeting timeline, quality, and compliance expectations. Working closely with Elligo’s Operations leaders, this individual will oversee the execution of clinical trial activities in compliance with all applicable regulations. They will provide quality study expertise while also training and mentoring staff to enhance performance and adherence to best practices.

This role requires close collaboration with cross-functional teams, including program leadership, to develop and implement training programs and provide quality oversight within each site. Responsibilities include creating and teaching key trainings, initial certifications, and maintaining records of annual trainings and recertification. By leveraging their expertise in learning and development, this individual will craft and execute a strategic training approach that enhances performance, drives business outcomes, and supports the success of the organization. This role is also the conduit to ensure compliance and audits are being conducted to standards set by the compliance department.

ESSENTIAL DUTIES:

• Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies. 
• Develop and refine staff training, processes, SOPs, and technology systems requirements, training & implementation to streamline efficiency, consistency and scalability of Elligo operations. 
• Design, update, and manage detailed training materials and documentation customized to address the diverse aspects of clinical trials. 
• Coordinate communication between practices and internal teams to streamline processes and ensure alignment on goals. 
• Support initiatives of internal and external groups (such as Learning and Development, Compliance, manufacturer leadership) as a program operations expert for continued development of enhanced training programs to support operations
• Provide guidance and mentorship to project team to ensure quality standards are met and needs of training programs are being met
• Provide recommendations on executional aspects of research operations, including risk identification and mitigation, to manage study or clinic nuances.
• Ensure operational excellence and integrity through adherence with Elligo policies and procedures, client requirements, ICH GCP, FDA, and other relevant regulatory requirements.
• Responsible for the assurance of all site staff complete required trainings.
• Responsible for identifying and monitoring trends from reviewing monitoring communication and recommending training initiatives when necessary.
• Collaborate with Research Operations and Medical Affairs to ensure site compliance with regulations and proactively identify and mitigate risks, manage quality events identified at a site level. 
• Perform other duties as required or assigned. 

SUPERVISORY RESPONSIBILITIES:

None

QUALIFICATIONS: 

• The ability to create and deliver training presentations, during both small and large group trainings, to customers, peers, and prospects, with measurable results.
• Expertise in providing quality oversight, including monitoring compliance with regulatory requirements, implementing quality assurance processes, identifying areas for improvement, and ensuring adherence to standard operating procedures (SOPs). 
• Ability to work with functional groups and different levels of employees throughout Elligo to achieve business results effectively and professionally.
• Proactive and timely follow-up skills: the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
• Exceptional written and verbal communication skills, including the ability to present ideas and suggestions clearly and effectively.
• Strong organizational skills: ability to accomplish multiple tasks within the agreed-upon timeframes through effective prioritization of duties and functions in a fast-paced environment.
• Proven track record of building and maintaining solid relationships with both internal and external stakeholders.
• Self-motivated; able to work independently to complete tasks, respond to department requests and collaborate with others to utilize their resources and knowledge to identify quality solutions.
• Proven track record of healthcare industry or research experience and building successful relationships. 
• Demonstrated ability to be a prompt decision maker with strong problem-solving skills, while maintaining a high degree of flexibility in adapting to a rapidly changing environment.
• Advanced proficiency in Microsoft 365 applications (Outlook, Excel, Word, Teams and PowerPoint) and SharePoint.

EDUCATION AND EXPERIENCE: 

• Bachelor’s degree (BA/BS) in Business, Life Sciences or a related field or an Associate degree with at least 4 years of experience in direct or indirect (such as clinical trials, decentralized trials, life sciences, healthcare)
• Minimum 5 years of experience in clinical research, preferably with prior clinical research site management experience. 
• Minimum 4 years of experience providing quality and regulatory oversight 
• Minimum 2 years of experience working with site networks is preferred.
• Minimum 4 years of experience with training and mentoring other clinical research professionals.