Study Start-Up Specialist: Regulatory & Site Activation Lead

IQVIA LLC; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

IQVIA is seeking a Site Activation/Project Coordination professional to act as the Single Point of Contact for investigative sites and internal teams. You will lead start-up and activation activities, ensuring regulatory documents are accurate and timelines are met, while maintaining internal systems and metrics.

Incumbents bring a background in clinical research with GCP/ICH knowledge and familiarity with regulatory requirements to support project planning and sponsor communications.

Qualifications

• 3 years clinical research 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.

Responsibilities

• Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to SOPs, Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Education

Bachelor's Degree in life sciences or a related field

Job description

IQVIA is seeking a Site Activation/Project Coordination professional to act as the Single Point of Contact for investigative sites and internal teams. You will lead start-up and activation activities, ensuring regulatory documents are accurate and timelines are met, while maintaining internal systems and metrics.

Incumbents bring a background in clinical research with GCP/ICH knowledge and familiarity with regulatory requirements to support project planning and sponsor communications.