RSU Specialist 2 - IQVIA

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities following applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

• Under general supervision, 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 standard operating procedures (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 plans as needed.
• Inform team members of the 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 the project team during initial and ongoing project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualifications

• Bachelor’s Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training, and experience.
• 3 years clinical research experience, including 1-year experience in a leadership capacity.
• Equivalent combination of education, training, and experience.
• In-depth knowledge of clinical systems, procedures, and corporate standards.
• Good negotiating and communication skills with the ability to challenge, if applicable.
• Effective communication, organizational, and interpersonal skills.
• Ability to work independently and to effectively prioritize tasks.
• Ability to manage 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.