The Clinical Research Associate will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative / physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and / or all applicable local and federal regulatory requirements.
Performs all tasks routinely and independently, seeking guidance as needed.
immediately communicates / escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH / GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs / processes.
Demonstrates diligence in protecting the confidentiality of each subject / patient. Assesses factors that might affect subject / patient’s safety and clinical data integrity at an investigator / physician site such as protocol deviation / violations and pharmacovigilance issues.
oAssesses site processes
oConducts Source Document Review of appropriate site source documents and medical records
oVerifies required clinical data entered in the case report form (CRF) is accurate and complete
oApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
oUtilizes available hardware and software to support the effective conduct of the clinical study data review and capture
oVerifies site compliance with electronic data capture requirements
Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP / local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released / returned.
Ensures the investigator / physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
Supports subject / patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
Must be able to quickly adapt to changing priorities to achieve goals / targets.
completes assigned training as required.
oSite support throughout the study lifecycle from site identification through close-out
oKnowledge of local requirements for real world late phase study designs
oChart abstraction activities and data collection
oCollaboration with Sponsor affiliates, medical science liaisons and local country staff
oThe SMA II may be requested to train junior staff
oIdentify and communicate out of scope activities to Lead CRA / Project Manager
oProactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations