Description
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
As a Home Based role requiring a RSU with contracts experience, you will:
- 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 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 regulatory 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 regulatory and contractual documents for individual sites
- Review, track and follow up the progress, the approval and execution of documents, 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