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Site Activation Coordinator

hace 2 semanas

Bogotá, Bogotá D.E., Colombia IQVIA Argentina A tiempo completo

Job Overview
Under general supervision, perform tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include feasibility or maintenance activities.

Essential Functions

• Under general supervision, perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.

• Prepare site documents, reviewing for completeness and accuracy.

• Inform team members of completion of regulatory contractual and other documents for individual sites.

• Distribute completed documents to sites and internal project team members.

• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.

• Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

Qualifications

• Bachelor's Degree in Life Science or related field.

• 2 years' experience in clinical research or 6 months in regulatory submissions in clinical research.

• Fluent in conversational (reading and writing) English.

• Established individual contributor who works under general supervision.

• Delivers objectives that significantly impact results for a job area.

• Tasks are not typically routine and may require applying discretion within broad operational boundaries and procedures.

• Problems faced are general and may require some analysis to resolve.

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