IQVIA
Clinical Research Associate, Sponsor Dedicated, Oncology or Immunology
IQVIA, San Diego, California, United States, 92189
Job OverviewJoin our team as a Clinical Research Site Manager, where you’ll play a crucial role in ensuring our study sites operate seamlessly and adhere to all protocols, regulations, and sponsor requirements.Essential Functions
Site Monitoring:
Conduct selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Recruitment Management:
Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs.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, case report form (CRF) completion, and data query resolution. Support the start-up phase as required.Documentation:
Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) according to GCP/ICH and local regulations.Mentorship:
Mentor clinical staff through co-monitoring and training visits.Collaboration:
Work closely with study team members to support project execution.Travel:
6-10 DoS per month typical expectation, can be exceptions given the nature of the position.Qualifications
Education:
BS Degree in a scientific discipline or healthcare preferred.Experience:
At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.Knowledge:
In-depth understanding of GCP and ICH guidelines.Skills:
Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads.Communication:
Strong written and verbal communication skills with a good command of the English language.Organization:
Excellent organizational and problem-solving skills.Management:
Effective time and financial management abilities.Interpersonal:
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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Site Monitoring:
Conduct selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.Recruitment Management:
Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs.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, case report form (CRF) completion, and data query resolution. Support the start-up phase as required.Documentation:
Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) according to GCP/ICH and local regulations.Mentorship:
Mentor clinical staff through co-monitoring and training visits.Collaboration:
Work closely with study team members to support project execution.Travel:
6-10 DoS per month typical expectation, can be exceptions given the nature of the position.Qualifications
Education:
BS Degree in a scientific discipline or healthcare preferred.Experience:
At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.Knowledge:
In-depth understanding of GCP and ICH guidelines.Skills:
Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads.Communication:
Strong written and verbal communication skills with a good command of the English language.Organization:
Excellent organizational and problem-solving skills.Management:
Effective time and financial management abilities.Interpersonal:
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
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