Site Activation Specialist/ Contract Negotiator

IQVIA; Lexington (KY); On-site; USD 49,000 - 123,000; Full time

Job summary

IQVIA is seeking a candidate to support feasibility, site activation, regulatory start-up, and ongoing maintenance activities at regional or country levels. The role involves preparing site documentation, reviewing contracts, and tracking performance metrics while ensuring all activities comply with regulations and SOPs.

Under moderate supervision, you will coordinate with the Project Management team and other departments, review regulatory and ethics approvals, and help establish timelines for

Qualifications

• Comprehensive knowledge of regulatory documentation and SOPs.
• Experience coordinating clinical study activities across sites.

Responsibilities

• Execute feasibility, site activation, and maintenance activities per regulations and SOPs.
• Prepare and review site documents and contracts; manage site performance metrics.
• Serve as primary contact for investigative sites and track document completion.

Skills

Regulatory documentation

Project coordination

Education

Bachelor's degree in Life sciences or related field

Clinical research experience 1-3 years

Healthcare environment experience 3+ years

Job description

Job Overview

Under moderate supervision, executes the feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level.

Job Overview

Under moderate supervision, executes the feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines. With moderate oversight and supervision, perform tasks at a country/region level associated with site activation 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

• With moderate oversight and supervision, perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.
• Prepare site documents, reviewing for completeness and accuracy.
• Inform team members of completion of regulatory, contractual, and other documents for individual sites.
• Distribute completed documents to sites and internal project team members.
• Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• Review, track and follow up the progress, approval and execution of required documents such as questionnaires, CDAs, regulatory/ethics approvals, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications

• Bachelor's Degree Life sciences or a related field required and
• Other 1 - 3 years clinical research or other relevant experience; or equivalent combination of education, training and experience required
• With 3 years of experience in a healthcare environment, or 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 $49,200.00 - $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.