Under general supervision, perform tasks at a country 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. May also include maintenance activities.
Essential Functions
- Under general supervision, perform site activation 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 regulatory documents, reviewing for completeness and accuracy.
- Inform team members of completion of regulatory and contractual 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 documents, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
- Grade 12 with 1-year clinical research, administrative or other relevant experience a healthcare environment or equivalent combination of education, training and experience.
- Productive individual contributor who works under general supervision.
- Problems faced are generally routine but may require interpreting procedures or policies to resolve.
- Good interpersonal communication and organizational skills.
- Good knowledge of MS Office applications.
- Good attention to detail.
- General awareness clinical trial environment and drug development process.
- Ability to work on multiple projects.
- Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
