Regulatory and Start-Up Specialist 1

Job Overview

Perform tasks at a country level associated with Regulatory, Start-up (RSU), and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.

RESPONSIBILITIES

• Under general supervision, 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 project timelines.
• Perform Regulatory, Start-up, and Maintenance 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.
• Review, prepare and negotiate site contracts and budgets with sites, if applicable.
• 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 plans as needed.
• Inform team members of the completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, approval, and execution of documents, including contracts, regulatory, ethics, ICF, and IP Release documents, in line with project timelines.
• Provide local expertise to RSU leads and Project team during initial and ongoing project timelines planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.
• May perform Site Selection Visits if a trained monitor.
• May participate in feasibility and/or site identification activities.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Effective communication, organizational, planning, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to work on multiple projects.
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
• Knowledge of applicable regulatory requirements, including local regulations, SOPs, and the company’s Corporate Standards.
• 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.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s Degree in life sciences or a related field and 1 year‘s clinical research or other relevant experience; or equivalent combination of education, training, and experience.

PHYSICAL REQUIREMENTS

• Extensive use of keyboard requiring repetitive motion of fingers.
• Extensive use of telephone and face-to-face communication requires the accurate perception of speech.
• Regular sitting for extended periods of time.
• May require occasional travel.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions, and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity, and intellectual courage every step of the way.