Study Start up Specialist, IQVIA Biotech

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

Job summary

IQVIA, a leading global provider of clinical research services, is seeking a Site Activation Specialist to coordinate country-level SA activities and ensure compliance with applicable regulations and SOPs. You will serve as the SPOC for sites, SAMs, and project teams, driving timely regulatory deliverables and maintaining quality control.

The role involves startup and activation activities, regulatory document preparation, and ongoing data tracking.

Qualifications

• 1 year of clinical research experience.
• Site activation US and CAN ICF review experience required.
• Experience adapting country ICF for US/Canada regulatory requirements preferred.
• Experience reviewing informed consent elements via checklists and ICF/IP release documents.

Responsibilities

• Act as SPOC for sites, SAM, PM team and other departments to ensure SOP compliance and timelines.
• Conduct startup and site activation activities per regulations and SOPs, distributing documents to sites and team.
• Prepare site regulatory documents and review for completeness and accuracy.
• Maintain internal systems and project tracking tools with site information.
• Provide feedback on site performance metrics and project planning timelines.

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.
• Site activation US and CAN ICF review experience is required.
• Experience in adapting a country ICF for US and Canada regulatory requirements is preferred, but not required.
• Experience reviewing information consents for elements of consent using a checklist, site specific ICF and central IRB ICFs. Both site activation ICF and for revised ICF in study maintenance

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.