Description
We are seeking a Clinical Research Coordinator to join our team in Sofia, Bulgaria. The successful candidate will be responsible for reviewing, coordinating, and finalizing Global Informed Consent Form templates for all sponsor clinical studies managed by Development Operations.
The role involves:
- Reviewing Informed Consent Forms (ICFs) created by study teams against protocols, biological samples plans, and other documents to confirm accuracy
- Checking country-specific ICFs for accuracy against Master ICFs
- Reviewing RFIs and updating ICFs to address queries
- Tracking progress of ICF template language reviews and escalations
- Co-managing the centralized Informed Consent Form mailbox
Additionally, the role may involve:
- Serving as a Single Point of Contact (SPOC) for investigative sites, Site Activation Managers, Project Management teams, and other departments
- Ensuring adherence to standard operating procedures (SOPs), Work Instructions (WIs), and project timelines
- Performing site activation activities according to applicable regulations, SOPs, and work instructions
- Distributing completed documents to sites and internal project team members
- Preparing site regulatory documents and reviewing for completeness and accuracy
The ideal candidate will have:
- A Bachelor's degree in life sciences or a related field and 3 years of clinical research experience
- At least 2 years of experience in reviewing ICFs, with experience in reviewing ICFs for multiple countries, including EU/EEA
- Knowledge of CTIS and experience with reviewing ICFs before and after EU submissions
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills, with the ability to challenge when necessary
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines