Clinical Research Associate

About the Role

With limited guidance, responsible for remote site monitoring activities to ensure sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. May monitor and/or co-monitor on-site when needed. May perform Site Identification (Site ID) and/or Site Start-Up (SSU) activities.

Responsibilities

• Complete therapeutic, protocol and clinical research training to perform job duties.
• Work collaboratively with Clinical Operations Lead (COL), Project Management, Regulatory Start-Up (RSU) and Epidemiology.
• Perform Site ID and site selection activities: collect Site Information Form (SIF) and Confidentiality Disclosure Agreement (CDA), track and file documents, and perform Site Selection Visits (SSVs) as needed.
• Perform SSU activities: prepare regulatory/ethics submission packages and obtain approvals; collect and review regulatory documents for completeness and accuracy; track and file site regulatory documents; prepare, review and negotiate site contracts and budgets; review and agree on project planning and timelines.
• Perform initiation, monitoring and close-out visits remotely and in accordance with contracted scope of work, using Good Clinical Practices (GCP), applicable regulations, SOPs and work instructions; may monitor and/or co-monitor on-site when needed.
• Serve as primary contact between the business and investigator site; ensure proper documentation of site management communications and serve as back-up to other Site Managers.
• Collaborate with assigned field CRAs on routine site management activities including site training, assistance with site questions, patient recruitment and retention management, study supplies management, and resolving/documenting outstanding site issues/action items.
• Review quality and integrity of patient data through remote review of electronic Case Report Form (CRF) data; ensure timely transmission of clinical data and work with sites to resolve data queries; assist with final data review, query resolution and database lock activities.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools; submit regular visit reports, generate follow-up letters, collect and file essential documents and other required study documentation.
• Provide input and updates to the assigned COL regarding site status and deliverables; escalate issues and/or risks related to site performance to the COL, Clinical Project Manager (CPM) and/or Line Manager (LM) as needed.
• Request onsite visits and/or site audits when necessary; assist with Investigator Meetings and site payments as required; may conduct assessment visits and provide assistance to less experienced clinical staff.

Qualifications

• Bachelor's Degree preferred or as required by local country policies; degree in a scientific discipline or health care preferred.
• Minimum of 2+ years of relevant clinical experience preferred; equivalent combination of education, training and experience may be acceptable.
• Intermediate knowledge of clinical research process and medical terminology; intermediate knowledge of ICH/GCP guidelines and applicable regulations; skill in understanding different study designs.
• Ability to understand electronic data capture including basic data processing functions.
• Written and verbal communication skills including good command of English; good organizational and problem-solving skills; ability to manage multiple priorities, meet deadlines and work independently with guidance as needed.
• Computer skills including proficient use of Microsoft Word and Excel.

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

Additional Information

• Work arrangement: hybrid.
• Employment type: full-time.