Sr Site Activation Specialist

NCBioImpact; Durham (NC); On-site; USD 63,000 - 157,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services and healthcare insights. This role focuses on Site Activation activities at country level, ensuring SOP/compliance, and supporting project timelines through active site coordination and quality control.

The position covers feasibility, site activation, regulatory documentation, and interaction with sponsors. Equal opportunity employer; base pay ranges are provided depending on qualifications and location.

Qualifications

• Bachelor's degree in life sciences or related field required.
• At least 3 years of clinical research or related experience; or equivalent combination.
• 3 years clinical research experience, including 1 year in a leadership capacity.

Responsibilities

• Under general supervision, serve as SPOC in assigned studies for investigative sites, SAM, PM team, and other departments.
• Perform feasibility, site ID, start up and site activation activities according to regulations, SOPs and WI.
• Prepare site documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and timelines; monitor measures and contingency plans.

Skills

Leadership

Clinical research

Regulatory awareness

Education

Bachelor's degree Life science or related field

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 activitie. Developing professional individual contributor who works under moderate oversight and supervision. Responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area. Problems faced are general and may require understanding of broader set of issues but are not complex.

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 feasibility, site ID, 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 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 fesibility, site ID, regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, 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 Life science or related field Req And
• Other 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. Req

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 $62,800.00 - $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.