Regulatory & Start-Up Coordinator

**Job Family Description**
**Sub-Family Description**
Manages and executes the site identification process and performs regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements either at the global, regional, or country level. Prepares and manages site regulatory documentation;
reviews and negotiates site regulatory documents and contracts with sites and sponsors;
maintains, reviews, andreports on site performance metrics;
serves as the primary point of contact for investigative sites;
tracks completion of regulatory and contractual documents for sites;
ensures contracts are fully executed;
and establishes projecttimelines.
**Summary**
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.
**Responsibilities**
- 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.
**Experience** &
Education**
- Grade12 and a minimum of 2 - 5 years of experience in an administrative environment.
**Required Skills**:
- Able to communicate clearly and accurately
- Fluent in English (verbal and written)
- Excellent organisational skills
- Pay attention to detail