Sponsor Dedicated Regulatory & Start-Up Specialist 2
$60,300–$157,100 year
RemoteUnited States
Job Summary
Serve as Single Point of Contact for investigative sites, managing site activation and maintenance activities in accordance with local regulations and SOPs. Prepare and review site regulatory documents for completeness, distribute completed deliverables to internal teams, and perform quality control on documents provided by sites. Track and follow up on the approval and execution of regulatory, ethics, and Investigator Pack release documents while maintaining internal systems and databases with project-specific information. Review site performance metrics, establish project timelines, and provide local expertise to the Site Activation Manager and project team during planning.
Required Qualifications
- Bachelor's Degree in life sciences or a related field
- 3 years' clinical research or other relevant experience
- 3 years clinical research experience
- 1 year experience in a leadership capacity
- Equivalent combination of education, training and experience
- 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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