FSP Regulatory & Start Up Specialist

Regulatory Toolkit; Durham (NC); On-site; USD 48,000 - 157,000; Full time

Job summary

IQVIA, a leader in clinical research services in the United States, seeks a Site Activation specialist to coordinate regulatory tasks at the country level, ensuring compliance with SOPs, WIs, and project timelines.

You will act as SPOC for investigative sites, manage startup activities, review documents, and provide local regulatory expertise to the SAM and project team. A life sciences degree and 3 years of clinical research experience with leadership are required.

Qualifications

• Bachelor's degree in life sciences with 3 years clinical research or related experience.
• Solid knowledge of GCP/ICH and regulatory guidelines.
• Strong negotiation, communication, and interpersonal skills.
• Ability to manage multiple projects and work independently.
• Experience leading projects or teams is a plus.

Responsibilities

• Serve as SPOC for investigative sites, SAM, and project teams to ensure SOPs and timelines.
• Perform startup and activation activities per regulations and SOPs; distribute documents to sites and team.
• Prepare and review site regulatory documents for completeness and accuracy.
• Maintain internal systems and databases with project-specific information.
• Review performance metrics and provide management feedback.
• Monitor timelines and implement contingency plans as needed.
• Inform team of regulatory and contractual document completion for sites.
• Review, track and coordinate document approvals and IP release in line with timelines.
• Provide local regulatory expertise during initial and ongoing project planning.
• Perform quality control of documents provided by sites.
• May interact with sponsors on specific initiatives.

Job description

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with 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 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.

Qualifications

• 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 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 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $47,700.00 - $157,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.