The Clinical Research Associate I (CRA II) 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.
Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-
GCP and / or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-
specific actions; 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 via review of site source documents and medical records
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.
specific site team members are trained and compliant with applicable requirements.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities.
Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.
The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.
Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.