Sr. CRA, Sponsor Aligned, Oncology
Sr. CRA, Sponsor Aligned, Oncology
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$ 57500 - 226800
1 Vacancy
Job Description
Job Overview:
Join our dynamic team as a Clinical Research Associate! Youll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols regulations and sponsor requirements. Be at the forefront of groundbreaking cancer research and make a real impact on patients lives.
Key Responsibilities
Site Monitoring Visits: Conduct selection initiation monitoring and close-out visits in line with GCP and ICH guidelines.
Subject Recruitment: Collaborate with sites to develop and track recruitment plans ensuring project needs are met.
Training & Communication: Provide protocol and study training to sites maintaining regular communication to manage expectations and address issues.
Quality Assurance: Assess site practices for protocol adherence and regulatory compliance escalating quality issues as needed.
Study Progress Management: Oversee regulatory submissions recruitment enrollment CRF completion and data query resolution. Support start-up phases as required.
Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigators Site File (ISF) per GCP/ICH and local regulations.
Reporting: Generate visit reports follow-up letters and other necessary documentation.
Mentorship: Mentor clinical staff through co-monitoring and training visits.
Collaboration: Work closely with study team members to support project execution.
Qualifications
Education: BS degree required; a degree in a scientific discipline or healthcare is preferred.
Experience: 3 years of on site oncology monitoring experience strongly preferred. 1.5 years of oncology monitoring experience can be considered. Phase 1 oncology experience is required.
Skills:
Proficient in GCP and ICH guidelines.
Strong therapeutic and protocol knowledge in Phase 1 oncology trials.
Excellent computer skills including Microsoft Office and mobile devices.
Effective communication organizational and problem-solving abilities.
Strong time management skills.
Ability to build and maintain effective working relationships.
Why Join Us
Be part of a team thats pushing the boundaries of cancer research. Youll have the opportunity to work on cutting-edge Phase 1 oncology trials collaborate with top professionals in the field and contribute to life-changing advancements in cancer treatment. If youre passionate about making a difference and have the expertise were looking for wed love to hear from you!
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
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. potential base pay range for this role when annualized is $57500.00 - $226800.00. 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.
Required Experience:
Senior IC
Employment Type
Full-Time
