FSP Regulatory & Start Up Specialist 2

Socket.dev; Durham (NC); On-site; USD 60,000 - 157,000; Full time

Job summary

IQVIA, a global leader in clinical research, seeks a Site Activation professional to coordinate startup activities, regulatory document review, and cross-functional collaboration. You will ensure SOP compliance, maintain data integrity, and support timelines for multiple sites.

You will leverage GCP/ICH knowledge, leadership experience, and strong communication to drive quality, efficiency, and regulatory adherence across projects.

Qualifications

• Bachelor's degree in life sciences or a related field; 3 years clinical research or equivalent experience.
• 3 years clinical research with at least 1 year in a leadership capacity.
• Deep knowledge of clinical systems, procedures, and corporate standards.
• Strong negotiation and communication abilities for challenging situations.
• Excellent communication, organizational, and interpersonal skills.
• Ability to work independently and prioritize tasks.
• Ability to manage multiple projects concurrently.
• Knowledge of GCP/ICH and regulatory guidelines.
• Familiarity with regulatory requirements and SOPs.

Responsibilities

• Serve as Single Point of Contact for investigative sites, SAMs, and project teams.
• Conduct startup and site activation activities per regulations and SOPs.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain accuracy of internal systems and project databases.
• Provide feedback on site performance metrics to management.
• Plan project timelines and implement contingency measures as needed.
• Inform teams about completion of regulatory and IP release documents.
• Ensure tracking and progress of regulatory, ethics, ICF, and IP approvals.
• Provide local expertise during initial and ongoing project planning.
• Perform quality control on documents supplied by sites.
• May liaise with sponsors on specific initiatives.

Skills

Negotiation skills

Communication

Independent work

Multi-project management

GCP/ICH knowledge

Regulatory knowledge

Timeline prioritization

Education

Bachelor's degree in life sciences or related field

3 years clinical research with leadership

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 $60,300.00 - $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.