What are the responsibilities and job description for the Clinical Research Associate, Sponsor Dedicated, Oncology or Immunology position at 5PY US Quintiles, Inc.?
Job Overview
Join our team as a Clinical Research Site Manager, where you’ll play a crucial role in ensuring our study sites operate seamlessly and adhere to all protocols, regulations, and sponsor requirements.
Essential Functions
- Site Monitoring: Conduct selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Recruitment Management: Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs.
- Training & Communication: Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
- Quality Assurance: Evaluate site practices for protocol adherence and escalate quality issues as needed.
- Study Progress: Track regulatory submissions, recruitment, enrollment, case report form (CRF) completion, and data query resolution. Support the start-up phase as required.
- Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) according to GCP/ICH and local regulations.
- Mentorship: Mentor clinical staff through co-monitoring and training visits.
- Collaboration: Work closely with study team members to support project execution.
- Travel: 6-10 DoS per month typical expectation, can be exceptions given the nature of the position.
Qualifications
- Education: BS Degree in a scientific discipline or healthcare preferred.
- Experience: At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.
- Knowledge: In-depth understanding of GCP and ICH guidelines.
- Skills: Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads.
- Communication: Strong written and verbal communication skills with a good command of the English language.
- Organization: Excellent organizational and problem-solving skills.
- Management: Effective time and financial management abilities.
- Interpersonal: 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
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $87,200.00 - $189,000.00. 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.Salary : $87,200 - $189,000
