Operations Quality Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

An In-house Clinical Research Associate will work closely with the Clinical Research Associates (CRAs) by providing centralized support to regional team members, assisting with the preparation, organization and follow-up of investigator/site communications and clinical monitoring tracking at a site, regional and global level. In addition, the Inhouse CRA will liaise with the study team to ensure study information is proper communication to the site and CRAs.

What You Will Do:

Provide general support to the CRAs to manage investigational sites and ensure protocol and regulatory compliance, remotely reviews EDC

• Remotely reviews drug accountability log (when possible)
• Ensures study systems are updated per agreed study conventions (e.g. CTMS)
• To assist local SSU specialist with contracts negotiations and RGL’s site documentation
• Perform QC of the eTMF (country/site level) for a certain study
• Assist investigational sites with study start-up activities to ensure study specific supplies are received
• Assist with the development of training content (monitoring visit training materials, monitoring visit reports, etc.) as needed
• To contact Clinical sites for specific requests between visits:
  • Enrollment updates, challenges with recruitment, supplies
  • Missing TMF documentation
  • Data entry timelines, data query follow-up
  • Follow-up on action items from previous site visits
• Track patient enrollment and assist with recruitment efforts by maintaining regular site contact
• To assist CRAs with preparation and follow-up for all types of site visits (Communicating data entry, queries, tracking reports IRT/DM/Imaging/eCOA/Labs, TMF support and maintenance, site performance, point of escalation, etc.)
• Serve as primary CRA back-up for the site
• May assist with tracking project specific training for site personnel
• Conduct pre-study visits and/or Close-out Visits as needed; Independently as approved
• Co-monitor on assigned studies as needed
• Assist with site quality management activities, including site audits and site inspections
• Assist the CRA with Action Item and Protocol Deviation review and follow-up
• Maintain FAQ list for assigned studies, as needed
• Document site and sponsor contact and study interactions in a timely and professional manner
• Assist with resolution of investigational site data queries, especially during interim activities and DB Lock
• May provide study-specific direction, training, and mentoring to the monitoring team members

Your Profile:

• Position requires BA/BS preferably in the Life Sciences, or RN
• Minimum of 2-3 years of clinical research experience as Sponsor CTS/CTA or Site Coordinator
• Possess excellent understanding and working knowledge of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, and other relevant, local regulatory requirements
• Strong knowledge of concepts of clinical research and drug development
• Strong working knowledge of EDC, IVRS and CTMS systems
• Proficient in the use of Microsoft Office
• Ability to work highly independently across multiple studies, projects and sites.
• Ability to work effectively in a team/matrix environment.
• Ability to understand technical, scientific and medical information.
• Demonstrated strengths in planning, organizational, project management, analytical, oral and written communication, effective time management, conflict management, problem solving, attention to detail, and interpersonal skills
• Works with high quality and compliance mindset

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.