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 developing professional individual contributor, you will work under moderate oversight and supervision, making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area.
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.
- Perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions.
- 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.
- Establish and agree on project planning and project timelines.
- Inform team members of completion of feasibility, 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.
Qualifications
- Based in Argentina or Brazil.
- Bachelor's Degree in Life science or related field mandatory.
- 3 years clinical research experience supporting site activation/regulatory tasks.
- Advanced level of English is mandatory.