
Clinical Research Associate II Position
3 days ago
Job Opportunity:
Clinical research plays a vital role in ensuring the integrity and quality of clinical trials. As a Clinical Research Associate II, you will be responsible for conducting site qualification, initiation, monitoring, and close-out visits to ensure regulatory compliance, data accuracy, and subject safety.
- Main Responsibilities:
- Conduct site qualification, initiation, interim monitoring, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance
- Verify informed consent and maintain confidentiality of subjects/patients
- Assess factors affecting subject/patient safety and clinical data integrity
- Conduct source document review, verify clinical data, and resolve queries remotely and on-site
- Support investigational product inventory, reconciliation, and storage security
- Review Investigator Site File (ISF) for accuracy, timeliness, and completeness
- Document activities via confirmation letters, follow-up letters, trip reports, and communication logs
- Enter data into tracking systems to track observations, status, and action items
- Serve as primary liaison with study site personnel and ensure sites are trained and compliant with applicable requirements
- Participate in global clinical monitoring/project staff meetings and attend clinical training sessions
- Provide guidance towards audit readiness standards and support preparation for audits
Requirements and Qualifications:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
We Offer:
A challenging and rewarding career opportunity with a dynamic organization. If you possess the necessary skills and qualifications, we encourage you to apply.
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