Job Overview:
Join our dynamic team as a Clinical Research Associate! You'll 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 Investigator's 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 that's pushing the boundaries of cancer research. You'll 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 you're passionate about making a difference and have the expertise we're looking for, we'd 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.
The potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. 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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
...areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Job title: Data Entry Coordinator Job location: Research Triangle Park NC Duration: 12+ months (possibilities of extension) ROLES Data...
What is The Role We're looking for a Senior Software Engineer to join the Elasticsearch - Analytical Engine team. This expert team of engineers is responsible for building new analytics capabilities in Elasticsearchs new compute engine, and accessed via our new piped...
...Employment Type: Travel Shift/hours- 10:30p-7a, M-F; No call and no weekends Minimum of 1 year experience required SIEMENS EXPERIENCE REQUIRED System Type- Siemens Aera/Skyra/Sola Procedures/Scans- Neuro/Body/MSK/Breast Credentialing/Licensure...
...electronic and physical files; Respond to emails and phone calls in a timely and professional manner; Prepare and edit documents, presentations, and spreadsheets; Coordinate and facilitate virtual meetings; Assist with data entry and record keeping...Hiring Immediately...
...passion for making a meaningful impact? Machiahs House is seeking dedicated and experienced individuals to join our Board of Directors as volunteer board members. Help us guide the future of our organization as we work to secure and provide safe transitional housing, life...