Easter Seals Jobs

The Sr. Site Activation Specialist will perform tasks at a country level associated with Site Activation (SA) activities for North American sites in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

• Perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.

• Prepare site documents, reviewing for completeness and accuracy.

• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

• Review and provide feedback to management on site performance metrics.

• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.

• Inform team members of completion of fesibility, site ID, regulatory and contractual documents for individual sites.

• Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.

• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.

• Perform quality control of documents provided by sites.

• May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor's Degree Life science or related field

• Around 3-4 years clinical research experience, with mandatory experience in the site activation and regulatory department (experience working with the US and Canada is desirable).

• Advanced level of English (you'll be working with sites in North America)

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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

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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