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.
Prepare site regulatory documents, reviewing for completeness and accuracy, and review, prepare and negotiate site contracts and budgets with sites, if applicable.
Ensure overall project efficiency and adherence to project timelines, and implement contingency plan as needed.
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
Single Point of Contact for investigative sites
Ensure adherence to SOPs and WIs
Regulatory and Start-up activities
Review and negotiate site contracts
Maintain internal systems and databases
GCP/ICH and applicable regulatory guidelines
Nice-to-have
Effective communication and interpersonal skills
Ability to work independently
Contribute to regulatory intelligence
Mentor and train less experienced staff
Key Requirements
Bachelor’s Degree in life sciences or related field
3 years’ clinical research experience
Knowledge of applicable regulatory requirements
Understanding of regulated clinical trial environment