Regulatory and Start Up Specialist 2
On-siteSofia, Sofia-Capital, Bulgaria
Job Summary
Serve as Single Point of Contact for assigned studies, performing site activation and maintenance activities in accordance with local regulations and SOPs. Prepare and review regulatory documents for completeness, ensuring accurate completion of internal systems and databases. Track and follow up on approval and execution of documents, including Informed Consent Forms and Investigator Packs, while providing local expertise to the project team. Review site performance metrics and establish contingency plans as needed. Bachelor's degree in life sciences with three years of clinical research experience is required. Full-time role based in the United States.
Required Qualifications
- Bachelor's Degree in life sciences or a related field
- 3 years' clinical research or other relevant experience
- Equivalent combination of education, training and experience
- 3 years clinical research experience
- 1 year experience in a leadership capacity
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills
- Ability to challenge
- Effective communication skills
- Organizational skills
- Interpersonal skills
- Ability to work independently
- Ability to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Knowledge of applicable regulatory requirements, including local regulations, SOPs and company's Corporate Standards
- Understanding of regulated clinical trial environment
- Knowledge of drug development process
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
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