Location: México | Full Home Based role

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.

• Prepare site documents, reviewing for completeness and accuracy

• Prepare and review site regulatory documents for completeness and accuracy.

• 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:

• Degree in Life Sciences.

• At least 2 years of clinical research experience, with at least 1 year in Regulatory & Start-Up.

• Advanced level of English.

• Excellent organizational and prioritization skills

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