Description
We are seeking a Site Activation Specialist to work full-time from home in Argentina.
As a Site Activation Specialist, you will 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. May also include maintenance activities.
Essential Functions
- 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.
- 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.
- Establish and agree on project planning and project timelines.
- 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.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
Qualifications
- Bachelor's degree
- 2+ years of clinical research experience, clinical trial assistant experience is a plus.
- Experience in clinical research regulatory activities in Argentina, including presentations to ethics committees and ANMAT (SSU and maintenance phases)
- Good command of English Language
- Excellent communication and interpersonal skills
- Excellent organization and prioritization skills