Regulatory Administrator, Bogota
What You'll Do:
- Staff Training Maintenance: Developing and maintaining a master file of all research staff and their regulatory documents to ensure that their CVs, MLs, GCP, and IATA training are up to date. Assign new and re-training as needed based on expiry.
- Regulatory document maintenance:
- Training Log maintenance: Preparing training logs based on central research team guidance, sending out for signatures, and ensuring signatures are obtained
- Delegation Log maintenance: Preparing delegation logs based on central research team guidance and sending them out for signatures and ensuring signatures are obtained
- IRB and new protocol documents: Any new regulatory documents that are generated - ensure that they are filed in the appropriate study folder - including consent forms
- Building Regulatory folders in Clinical.ly: At the start of a study, build regulatory folders and populate them with information based on the sponsor-provided table of contents.
- System Access Maintenance: Making sure appropriate parties have access to study systems depending on the scope of work/study delegations
- Other remote administrative duties as assigned including but not limited to Patient recruiting, Patient comms/study day management, and various other financial and administrative
- Undergraduate degree required (health-related field is a plus)
- Bilingual English (B2-C1) Level in English
- Great communication skills for building strong relationships
- Minimum of 1 years related experience with clinical research is a plus
- Ability to work within a team and fast space environment
- Very detail oriented
- You are a very motivated and self-initiative collaborator
- Tech Savvy- Ability to learn and manage new tools like Google Suite and other clinical research software.