About the Company
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We are committed to pushing the boundaries of human data science and transforming the development and commercialization of new medicines. With operations in more than 100 countries and a team of over 85,000 professionals, IQVIA offers unparalleled opportunities for career growth and impact. Join us in our mission to accelerate medical innovation and improve patient health.
Job Description
We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our dynamic team in Rochester, NY. This is an exceptional opportunity for a professional looking to advance their career in clinical research, with the added benefit of a comprehensive global relocation package. As a CRA, you will play a critical role in the oversight of clinical trials, ensuring compliance with protocols, good clinical practices (GCP), and regulatory requirements. You will monitor investigator sites, manage study documentation, and contribute to the successful execution of clinical studies, ultimately bringing innovative treatments to patients faster.
Key Responsibilities
- Conduct site qualification, initiation, monitoring, and close-out visits in accordance with ICH-GCP guidelines and applicable regulations.
- Verify the rights and well-being of human subjects are protected, and informed consent is appropriately obtained and documented.
- Ensure the quality and integrity of study data by reviewing source documents, Case Report Forms (CRFs), and electronic data capture (EDC) systems.
- Manage study-related documentation, including Trial Master File (TMF) maintenance and essential documents.
- Identify, resolve, and escalate site-related issues in a timely and effective manner.
- Provide ongoing support and training to investigational site staff to ensure adherence to study protocols.
- Review and manage investigational product accountability, ensuring proper storage, dispensing, and return.
- Prepare comprehensive visit reports and follow-up letters, documenting all activities and findings.
- Participate in investigator meetings and internal project team meetings as required.
Required Skills
- Bachelor's degree in a life science, nursing, or related health field.
- Minimum of 1 year of experience as a Clinical Research Associate or equivalent clinical research experience.
- Thorough knowledge of ICH-GCP guidelines, FDA regulations, and other applicable local regulations.
- Excellent communication, organizational, and interpersonal skills.
- Ability to work independently and as part of a team.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Strong problem-solving abilities and attention to detail.
- Valid driver's license and ability to travel frequently.
Preferred Qualifications
- Master's degree or higher in a relevant scientific discipline.
- CCRA certification (Certified Clinical Research Associate).
- Experience with various therapeutic areas, particularly oncology, cardiovascular, or CNS.
- Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
Perks & Benefits
- Competitive salary and performance-based bonuses.
- Comprehensive global relocation package, including moving assistance and immigration support.
- Generous paid time off and holidays.
- Medical, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Life and disability insurance.
- Employee assistance program and wellness initiatives.
- Tuition reimbursement and professional development opportunities.
- Company-sponsored training and certification programs.
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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