About the Company
IQVIA (NYSE: IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to fostering innovation and driving human health forward, operating in more than 100 countries. Our mission is to accelerate clinical development and commercialization, helping our clients to achieve their goals and improve patient outcomes.
Job Description
IQVIA is seeking a dedicated and experienced Clinical Research Associate (CRA) to join our dynamic team in Durham, NC. This role offers an unparalleled opportunity for a professional passionate about clinical trials and global health, complete with a comprehensive global relocation package. As a CRA, you will play a pivotal role in ensuring the integrity and quality of clinical trial data by monitoring investigator sites, adhering to protocols, and complying with regulatory requirements. You will be responsible for a portfolio of studies, collaborating closely with investigators and site staff to ensure timely and accurate data collection, patient safety, and overall study progress. This position requires strong communication skills, meticulous attention to detail, and a proactive approach to problem-solving. Join us and contribute to groundbreaking research that impacts lives worldwide.
Key Responsibilities
- Conducting pre-study, initiation, routine monitoring, and close-out visits for assigned sites in accordance with SOPs, GCP, and regulatory requirements.
- Verifying that investigator site staff are conducting the study according to the protocol, Good Clinical Practice (GCP), and all applicable regulatory requirements.
- Ensuring the protection of the rights and well-being of human subjects.
- Reviewing and verifying source documents and case report forms (CRFs) for accuracy, completeness, and adherence to protocol requirements.
- Assessing site performance and making recommendations for improvement.
- Managing investigational product accountability, including shipping, receipt, storage, and disposition.
- Providing training and guidance to site staff on protocol-specific procedures, data collection, and regulatory compliance.
- Preparing comprehensive monitoring visit reports and follow-up letters.
- Identifying and escalating potential issues or risks to study management.
- Participating in investigator meetings and other project-related meetings as required.
Required Skills
- Bachelor's degree in a life sciences field (e.g., Biology, Chemistry, Nursing, Pharmacy) or equivalent combination of education and experience.
- Minimum of 2 years (24 months) of independent on-site clinical monitoring experience.
- Thorough knowledge of Good Clinical Practice (GCP) and relevant regulatory guidelines (e.g., FDA, ICH).
- Excellent written and verbal communication skills.
- Strong organizational skills and attention to detail.
- Ability to work independently and manage multiple priorities effectively.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- Master's degree or higher in a relevant scientific or health-related discipline.
- Certification as a Clinical Research Associate (e.g., CCRA).
- Experience across various therapeutic areas, particularly oncology, cardiovascular, or neuroscience.
- Experience with electronic data capture (EDC) systems.
- Strong problem-solving and critical thinking abilities.
Perks & Benefits
- Comprehensive Global Relocation Package (including visa support, travel assistance, and initial housing support).
- Competitive salary and performance-based bonuses.
- Generous paid time off and holidays.
- Medical, dental, and vision insurance options.
- 401(k) retirement plan with company match.
- Life and disability insurance.
- Professional development and continuing education opportunities.
- Employee assistance program and wellness initiatives.
- Opportunity to work on cutting-edge clinical trials impacting global health.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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