IQVIA

Sr. CRA, Sponsor Aligned, Oncology

IQVIA$71K — $189K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • BS degree required; preferred in a scientific discipline or healthcare
  • 3+ years of onsite oncology monitoring experience strongly preferred
  • 1.5+ years of oncology monitoring experience may be considered
  • Phase 1 oncology experience is required
  • 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

Responsibilities

  • Conduct selection, initiation, monitoring, and close-out visits per GCP and ICH guidelines
  • Collaborate with sites to develop and track recruitment plans
  • Provide protocol and study training to sites, maintaining regular communication
  • Assess site practices for protocol adherence and regulatory compliance
  • Oversee regulatory submissions, recruitment, enrollment, and data query resolution
  • Ensure all site documents are filed correctly per regulations
  • Generate visit reports, follow-up letters, and needed documentation
  • Mentor clinical staff through co-monitoring and training visits
  • Work closely with study team members to support project execution

Benefits

  • Comprehensive health and welfare benefits
  • Potential for incentive plans and bonuses
  • Career development and training opportunities
  • Supportive work culture focusing on collaboration
  • Opportunity to be involved in groundbreaking cancer research
Full Job Description
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.

The potential base pay range for this role, when annualized, is $71,900.00 - $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.

About IQVIA

Innovex offers superior and creative advice to corporations. In addition, they raised venture capital for our own affiliate companies, in addition to having assisted clients in fund-raising efforts, new venture outreaches, and financing. Their engineers and technical staff offer varied backgrounds in manufacturing, high tech, product design, quality control, safety, biomechanics, and robotics.

IQVIA Careers

Join the vibrant team at IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the healthcare industry. IQVIA is recognized for its commitment to innovation, leadership in healthcare, and a culture that celebrates diversity and inclusion.

Work You’ll Do

At IQVIA, we offer job opportunities that empower you to leverage your skills and drive healthcare forward. Become part of a team that thrives on innovation and the pursuit of operational excellence, helping to improve patient outcomes across the globe.

Transform Your Career

IQVIA is the place where you can transform the world of healthcare while advancing your career. With a variety of positions available, from research and development to business analytics, IQVIA is at the forefront of the industry. Our leadership is committed to fostering a culture of growth and professional development, making IQVIA a prime environment for both seasoned professionals and those seeking an internship to kickstart their career.

Innovative Work Environment

Join over 50,000 dedicated professionals in a dynamic environment where technology meets healthcare. At IQVIA, innovation isn’t just a buzzword; it's the backbone of how we solve complex challenges. With cutting-edge resources and a collaborative global team, your work at IQVIA directly contributes to advancements in life sciences.

Career Development and Benefits

IQVIA believes in nurturing its team members not just as employees but as individuals seeking to grow their careers. We support this with unmatched benefits, diversity training, and opportunities for leadership development. Our commitment to your career growth is matched by our dedication to providing a supportive and inclusive workplace.

Explore Job Opportunities

Whether you’re looking for a full-time position, part-time work, or a graduate internship, IQVIA offers a range of employment options to match your career ambitions. Our hiring process is designed to be transparent and engaging, helping you to understand where your skills can best be utilized within the company.

Networking and Professional Development

At IQVIA, networking and professional development are part of our DNA. Engage with industry leaders, participate in global conferences, and take advantage of our in-house training programs designed to enhance your skills and advance your career.

Stay Connected

Join Our Team Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players. Explore the diverse job opportunities at IQVIA and find where you can make an impact.

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Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at IQVIA. Embark on a journey of growth, innovation, and leadership at IQVIA. Shape your future in an environment that values diversity and fosters professional development. Join IQVIA today and transform healthcare through the power of information and technology.
Learn more about IQVIA
Size
82,000 employees
Market Cap
$37.5 billion
Industry
Net Income
$279 million
Founded
2016
5 Year Trend
+15.3%
Revenue
$11.3 billion
NASDAQ

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