SUMMARY:

The Clinical Site Specialist (CSS) plays a pivotal role in supporting study execution and driving operational excellence across the IRO Site Network, with a primary focus on the Powered By region. Acting as a strategic partner to site employees, the CSS is directly accountable for site success and serves as a key contributor to Elligo's mission of advancing healthcare through effective clinical research.

The Clinical Site Specialist collaborates closely with Operations Leadership, Clinical Site Managers, Principal Investigators, and site-based staff to support all phases of study activity, from site qualification and onboarding through study closeout. Core responsibilities include site documentation management, regulatory submissions, recruitment reporting, study startup support, quality assurance activities, and KPI tracking.

The CSS may also be consulted on site payments, audit preparation, document review, and the preparation and submission of study documents to the site or IRB. Through this broad scope of support, the Clinical Site Specialist strengthens Elligo's site network, enhances clinical trial efficiency, and ensures sites are fully equipped to conduct high-quality research.

ESSENTIAL DUTIES:

• Collaborate with Operations Leadership, Clinical Site Managers, and site-based study staff to support overall site performance and operational goals.
• Manage and maintain site documentation, ensuring all records are accurate, compliant, and reflect the most current versions throughout the life of the study.
• Support the completion of site study startup documentation, facilitating timely and accurate submissions to meet study milestones.
• Attend Pre-Study Visits (PSVs), Site Initiation Visits (SIVs), and site calls as needed to support study activation and ongoing site oversight.
• Track and monitor departmental KPIs, contributing to performance reporting and continuous improvement initiatives.
• Conduct remote data entry as needed to support site compliance, data integrity, and overall study success.
• Works with Central Team CTLs, Clinical Site Managers, Principal Investigators (PIs), and site-based staff to facilitate seamless study execution across all phases.
• Develop and deliver comprehensive site reports encompassing recruitment metrics, study performance indicators, and pipeline updates to site staff.
• Provide site setup expertise, ensuring newly onboarded sites are properly qualified, trained, and operationally prepared to conduct clinical trials in accordance with regulatory and sponsor requirements.
• Support the onboarding of new site personnel, ensuring all required training completions and essential documentation are obtained and recorded prior to study participation.
• Liaise with site personnel to ensure all regulatory documents and submissions are completed accurately and submitted in a timely manner throughout the duration of each study.
• Support quality assurance activities, including audit preparation, internal review processes, and documentation management, while driving resolution of identified findings and action items.
• Serve as the primary site and client point of contact in the absence of the Clinical Site Manager, ensuring continuity of communication and site support.
• Perform additional duties as assigned in support of departmental and organizational objectives.

SUPERVISORY RESPONSIBILITIES:

None

QUALIFICATIONS:

• Ability to work with functional groups and different levels of employees throughout Elligo to achieve business results effectively and professionally.
• Proactive and strong follow-up skills: the ability to organize applicable department timelines and follow up with internal and external stakeholder needs as needed.
• Demonstrated attention to detail with strong documentation skills, including the ability to review and verify documents and data within Excel and other reporting tools to ensure accuracy, integrity, and compliance with regulatory standards and professional expectations for client-facing deliverables.
• Clear and concise written and oral 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.
• Proficient in Microsoft Excel and PowerPoint with the ability to create moderate to complex reports and presentations.
• Able to build relationships with ease both internally and externally.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree (BA/BS) in Life Sciences or a related field or Associate degree with at least 4 years of experience in direct or indirect (such as clinical trials, RWE, life sciences, healthcare)
• Minimum of one (2) years patient facing clinical research experience (including Study Coordinator, CRO experience) or working in a healthcare setting.
• 2 years or more experience as a Clinical Research Coordinator is preferred
• Previous GCP training and certification is preferred.
• Experience working with electronic medical records (EMRs); electronic health record system proficiency is preferred
• Thorough understanding of HIPAA privacy and security laws around PHI
• Data entry experience is preferred