Buenos Aires, Argentina
São Paulo, Brazil
Full time
R
Job Overview
Under moderate supervision, executes the feasibility, site identification regulatory and start-up activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.
Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines. With moderate oversight and 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 maintenance activities.
Essential Functions
- With moderate oversight and supervision, serve a Single Point of Contact (SPOC) to perform feasibility and site activation 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.
- Update and maintain 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. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.
Qualifications
- Bachelor's Degree Life sciences or a related field
- At least 1 year of clinical research experience
- Advanced level of English - you'll be working with North American sites
This is a junior role, idóneo for anyone with some experience that wants to pivot to the site activation role or that wants to learn new things __
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Clinical Trial Coordinator II - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Operations Delivery Associate II,



you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization’s SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations.
What You'll Do:
- According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
- Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s).
- Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
- Performs administrative tasks on assigned trials including but not limited to
- timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
- Reviews and tracks local regulatory documents.
- Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
- Assists with technical and administrative support for projects in collaboration with internal departments and team members.
- Maintains knowledge of and understands SOPs, client SOP

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