Clinical Research Associate II Role
Clinical research associates play a critical role in ensuring the integrity and quality of clinical trial data. As a Clinical Research Associate II, you will be a key member of our Clinical Development team, working closely with investigative sites to ensure compliance with regulations and industry standards.
* Conduct site qualification, initiation, monitoring, management, and close-out activities to guarantee regulatory, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP) compliance.
* Evaluate overall performance of sites and site staff, providing recommendations for site-specific actions.
Responsibilities
* Verify informed consent processes have been adequately performed and documented for each subject or patient.
* Assess factors affecting subject or patient safety and clinical data integrity at investigator or physician sites.
* Conduct Source Document Reviews of appropriate site source documents and medical records.
* Ensure accuracy and completeness of clinical data entered in case report forms (CRFs).
* Apply query resolution techniques remotely and on-site, driving closure within agreed timelines.
* Perform investigational product inventory, reconciliation, and reviews of storage and security.
* Verify issues or risks associated with blinded or randomized information related to investigational products.
* Routinely review Investigator Site Files (ISFs) for accuracy, timeliness, and completeness.
* Reconcile ISF contents with Trial Master Files (TMFs).
* Ensure investigator or physician sites are aware of archiving requirements in accordance with local guidelines and regulations.
* Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
Requirements
* Bachelor's degree or registered nurse in a related field, or equivalent combination of education, training, and experience.
* Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
* Excellent communication, presentation, and interpersonal skills.
* Able to manage required travel of up to 75% on a regular basis.