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IQVIA is recruiting for a mix role of Clinical Trial Assistant and Start Up Specialist. The successful candidate will have a CTA background and importantly have submission experience

RESPONSIBILITIES

· Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
· Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
· Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
· Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
· Perform quality control of documents provided by sites.
· May have direct contact with sponsors on specific initiatives.
· May perform Site Selection Visits if a trained monitor.
· May participate in feasibility and/or site identification activities.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

· In-depth knowledge of clinical systems, procedures, and corporate standards.
· Effective communication, organizational, planning and interpersonal skills.
· Ability to work independently and to effectively prioritize tasks.
· Ability to work on multiple projects.
· Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
· Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
· Clinical submission experience

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
· Bachelor’s Degree in life sciences or a related field and 1 year‘s clinical research or other relevant experience; or equivalent combination of education, training and experience.

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. Learn more at https://jobs.iqvia.com