Clinical Research Associate

RESPONSIBILITIES AND TASKS

* Review and provide input on requested trial-related documents and on any CRO prepared documents, e.g., protocol and protocol amendment, Informed Consent Form, Delegation of Authority, Case Report Form, Study-Specific Monitoring Plan (SSMP), trial forms, source document templates, Clinical Study Report

* Contribute to the collection and the quality control of essential documents

* Participate in and contribute to the Clinical Pharmacology trial team meetings by providing updates on monitoring activities * Contribute to the CRO/Site selection process by sharing any experience with a CRO/Site (when required)

* Perform accompanied visits, qualification visits (when required) and initiation visits as internally agreed for the assigned studies * Schedule and conduct routine remote and/or on-site monitoring visits and close-out visits at the frequency determined for the assigned studies, assuring that the CROs/Sites are delivering high quality research, overall integrity of study implementation, and adherence to the protocol

* Ensure that the conduct of the assigned trials complies with ICH-GCP Guidelines, local regulations, working instructions (WIS) and Standard Operating Procedures (SOPs)

* Identify CRO/Site issues, ensure resolution, and/or escalate issues if necessary

* Report to the Clinical Pharmacology trial team and the CRO/Site staff any findings noted during onsite and remote monitoring visits by completing contact reports,