What are the responsibilities and job description for the Study Start-Up Clinical Research Associate, Sponsor Dedicated position at IQVIA?
IQVIA is seeking Study Start-Up Clinical Research Associates to join our Sponsor Dedicated teams. Ideal candidates will have experience in Study Start-Up and at least 6 months of on-site or in-house monitoring experience. Candidates can be located anywhere in the United States.
Job Overview
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH/GCP, local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).
Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead, the SSO Study Start-Up Manager, and the SSO Feasibility Manager as well as the SSO Site Partnership Manager
Collaborates with the SSO Study Start-Up Manager, the SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
Conducts site selection visits, verifies site eligibility for a specific study
Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
Facilitates the preparation and collection of site and country level documents
Collects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g., FD, CV, GCP certificates, DSL, etc.)
Supports the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities
Prepares and finalizes site specific documents for submission
Negotiates investigator payments, as needed
Supports preparation of financial contracts between Sponsor and investigational sites and investigators, as needed
Updates all systems until site Green Light on an ongoing basis
Supports preparation of audits and inspections, as applicable
Supports reduction of formal site-specific IRB/IEC deficiencies
Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health
Authority and SOP requirements Implements innovative and efficient processes which are aligned with the sponsor strategy
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 $71,900.00 - $145,300.00. 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.
Job Overview
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials in the country in accordance with monitoring procedures and processes following ICH/GCP, local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).
Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead, the SSO Study Start-Up Manager, and the SSO Feasibility Manager as well as the SSO Site Partnership Manager
Collaborates with the SSO Study Start-Up Manager, the SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
Conducts site selection visits, verifies site eligibility for a specific study
Acts as the main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
Facilitates the preparation and collection of site and country level documents
Collects submission-related site-specific documents for all relevant site personnel within agreed timelines (e.g., FD, CV, GCP certificates, DSL, etc.)
Supports the SSU Manager with preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
Supports the SSO Study Start-Up Manager and assigned sites with vendor set-up activities
Prepares and finalizes site specific documents for submission
Negotiates investigator payments, as needed
Supports preparation of financial contracts between Sponsor and investigational sites and investigators, as needed
Updates all systems until site Green Light on an ongoing basis
Supports preparation of audits and inspections, as applicable
Supports reduction of formal site-specific IRB/IEC deficiencies
Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health
Authority and SOP requirements Implements innovative and efficient processes which are aligned with the sponsor strategy
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 $71,900.00 - $145,300.00. 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.
Salary : $71,900 - $145,300