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 will also undertake feasibility or maintenance activities as needed.
Key responsibilities include:
- Performing 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.
- Reviewing documents for completeness, consistency and accuracy, under guidance of senior staff.
- Preparing site documents, reviewing for completeness and accuracy.
- Informing team members of completion of regulatory, contractual and other documents for individual sites.
- Distributing completed documents to sites and internal project team members.
- Supporting the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
- Reviewing, tracking and following 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.
Requirements:
- Bachelor's Degree in Life science or related field.
- 2 years' experience in a healthcare environment or equivalent combination of education, training and experience.
- Established individual contributor who works under general supervision.
- Delivers objectives that significantly impact results for a job area.
- Tasks are not typically routine, and may require applying discretion within broad operational boundaries and procedures.
- Problems faced are general and may require some analysis to resolve.