IQVIA
Clinical Research Associate, Sponsor Dedicated, Oncology
IQVIA, San Diego, California, United States, 92189
Role Overview:
As a Clinical Research Associate, you’ll be at the forefront of ensuring our study sites operate smoothly and efficiently. Your work will be pivotal in advancing groundbreaking research.
Key Responsibilities:Site Visits:
Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Recruitment Drive:
Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.Training & Communication:
Provide protocol training and maintain regular communication with sites to manage expectations and address issues.Quality Assurance:
Evaluate site practices for protocol adherence and escalate quality issues as needed.Study Progress:
Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.Documentation:
Maintain essential documents in the Trial Master File (TMF) and Investigator’s Site File (ISF) as per regulatory requirements.Mentorship:
Mentor clinical staff through co-monitoring and training visits.Collaboration:
Work closely with study team members to support project execution.Financial Management:
Manage site finances and retrieve invoices as per local requirements.Qualifications:Education:
BS Degree in a scientific discipline or healthcare preferred.Experience:
Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.Knowledge:
Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.Skills:
Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.Attributes:
Effective time and financial management, and the ability to build strong working relationships.Why Join Us?
Be part of a team that’s driving innovation in clinical research. Your contributions will help shape the future of healthcare. Apply now and embark on a rewarding career journey with us!
#J-18808-Ljbffr
As a Clinical Research Associate, you’ll be at the forefront of ensuring our study sites operate smoothly and efficiently. Your work will be pivotal in advancing groundbreaking research.
Key Responsibilities:Site Visits:
Conduct selection, initiation, monitoring, and close-out visits, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Recruitment Drive:
Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.Training & Communication:
Provide protocol training and maintain regular communication with sites to manage expectations and address issues.Quality Assurance:
Evaluate site practices for protocol adherence and escalate quality issues as needed.Study Progress:
Track regulatory submissions, recruitment, enrollment, and data management to ensure smooth study progress.Documentation:
Maintain essential documents in the Trial Master File (TMF) and Investigator’s Site File (ISF) as per regulatory requirements.Mentorship:
Mentor clinical staff through co-monitoring and training visits.Collaboration:
Work closely with study team members to support project execution.Financial Management:
Manage site finances and retrieve invoices as per local requirements.Qualifications:Education:
BS Degree in a scientific discipline or healthcare preferred.Experience:
Minimum 1 year of on-site monitoring experience in oncology; 2 years preferred.Knowledge:
Strong understanding of GCP and ICH guidelines, with expertise in oncology protocols.Skills:
Proficiency in Microsoft Office, excellent communication skills, and strong organizational and problem-solving abilities.Attributes:
Effective time and financial management, and the ability to build strong working relationships.Why Join Us?
Be part of a team that’s driving innovation in clinical research. Your contributions will help shape the future of healthcare. Apply now and embark on a rewarding career journey with us!
#J-18808-Ljbffr