Description
Under general supervision, you will 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.
You may also be involved in feasibility or maintenance activities.
Essential Functions
- 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 a CRO or over 4 years of experience in a site, with previous experience in regulatory/site activation tasks.
- Advanced level of English is mandatory, as you will be in touch with sites from North America.
This is a home-based role.