Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS
Job Summary
Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
Matching Summary
Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
Skills & Requirements
Must-have
Serve as Single Point of Contact
Ensure adherence to SOPs and WIs
Prepare site regulatory documents
Review and negotiate site contracts
Maintain internal systems and databases
Ensure project efficiency and timelines
Nice-to-have
Contribute to regulatory intelligence
Assist in pre-award activities
Provide input into contract templates
Act as Local Regulatory Expert
Mentor less experienced staff
Key Requirements
Bachelor’s Degree in life sciences or related field
3 years clinical research experience
Knowledge of GCP/ICH and regulatory guidelines
Understanding of regulated clinical trial environment