About this role

Perform tasks at a country level associated with Site Activation (SA) activities
Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites
Ensure adherence to standard operating procedures (SOPs) and project timelines
Perform start up and site activation activities according to applicable regulations
Prepare site regulatory documents, reviewing for completeness and accuracy
Provide local expertise to SAMs and project team during initial and on-going project timeline planning
Perform quality control of documents provided by sites

Bachelor’s Degree in life sciences or a related field
3 years’ clinical research or other relevant experience
In-depth knowledge of clinical systems, procedures, and corporate standards
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
Understanding of regulated clinical trial environment and knowledge of drug development process
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Regulatory and Start Up Specialist

Key skills