Regulatory & Start-Up Specialist 1

IQVIA; Durham (NC); On-site; USD 48,000 - 123,000; Full time

Job summary

IQVIA in the United States is seeking a Site Activation Specialist to drive country-level SA activities in accordance with SOPs, regulatory standards, and project requirements. You will collaborate with sites, Site Activation Managers, and the project management team to ensure timely activation and compliant documentation.

The role emphasizes startup activities, regulatory document preparation, data tracking, and performance reviews, with a focus on adherence to timelines.

Qualifications

• Minimum 1 year of clinical research experience.
• Equivalent combination of education, training and experience may be considered.

Responsibilities

• Serve as SPOC for investigative sites and project teams, ensuring SOP/WI compliance.
• Perform start-up and site activation activities per regulations and SOPs.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems with project-specific data and tracking tools.
• Review site performance metrics and provide feedback to management.
• Coordinate project timelines and ensure contingency planning is in place.
• Provide local expertise to SAMs during planning and execution.
• Quality control documents provided by sites.
• May have direct contact with sponsors on initiatives.

Skills

Clinical research experience

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

• 1 year clinical research experience. Equivalent combination of education, training and experience.

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 - $123,000.00. 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.