Clinical Research Associate

  • Remote, USA, United States
  • Contract
  • Department: Clinical Sciences

Company Description

Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies in disease areas of high unmet medical need. We are currently developing voclosporin, an investigational drug, for the treatment of Lupus Nephritis (LN) and focal segmental glomerulosclerosis (FSGS). Additionally, we are advancing voclosporin ophthalmic solution (VOS), a topical formulation, for the treatment of dry eye syndrome (DES).

Job Description

The Clinical Research Associate (CRA) monitors the setup, management, and maintenance of clinical trials to ensure compliance and good quality data at clinical sites conducting research studies by Aurinia Pharmaceuticals Inc. The CRA is responsible for supporting the clinical study teams in the execution of all clinical trials being conducted by Aurinia Pharmaceuticals Inc. The CRA oversees the progress of clinical investigations by conducting pre-study, initiation, interim, and closeout visits to sites and monitors clinical trials in accordance with GCPs and procedures set forth by CRO partners and Aurinia. The CRA also may identify collaborating investigators and research centers, representing CROS to hospitals, clinics, physicians, etc. Conducts visits to study sites to determine compliance with protocol guidelines and with federal regulatory requirements, prepares documentation required for successful implementation, monitoring, and evaluation of clinical trials.

Primary Responsibilities
• Performs all clinical monitoring duties according to GCPs and required SOP
• Works with assigned CRO partner and within CRO systems (i.e. CTMS, SOPs) to monitor clinical sites for, and represent Aurinia Pharmaceuticals
• Assists the Clinical Project Manager in the management and supervision of assigned regions and sites
• Recruits and performs initial qualification of new investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study including the investigator’s experience, qualifications, adequacy of facility, equipment and staff, patient population, laboratory facilities and adequacy for drug storage. Assist with site contract and budget negotiations
• Coordinates activities with the site in preparation for the initiation of studies. Obtains and reviews FDA regulatory documentation and CRO required paperwork, prior to shipment of clinical trial materials
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, the study procedures and timelines, and instructions for the preparation of the CRFs
• Serves as primary contact with assigned sites, maintaining frequent telephone and written communication with the principal investigator and staff to provide and exchange information and/or resolve problems
• Performs interim monitoring visits. Performs validation of source documents as required and CRF review for accuracy and completeness of data. Monitors protocol compliance and integrity of randomization and blinding conditions
• Reviews CRO and investigator’s study files and ensures compliance with GCPs and CRO SOPs and collects required documents for TMF
• Prepares adequately documented monitoring reports and letters in a timely manner using approved business writing standards
• Monitors and verifies the investigators adherence to FDA regulations regarding conducting clinical research including protocol compliance, IRB requirements, informed consent elements, drug accountability procedures, adverse event reporting, sponsor and investigator responsibilities, and regulatory documentation
• Documents accountability, stability, and storage conditions of clinical trial materials. Performs study closure visits. Performs drug inventory and at the end of the study ensures return of unused materials to pre-arranged destination
• Works with the Data Management to resolve data queries
• Assists team by performing quality control procedures and clinical review of collected data
• Participates, as needed, in the preparation and review of clinical protocols and protocol amendments
• Participates in the design and review of CRFs, CRF guidelines, patient consents, and patient diaries as per protocol specifications
• Prepares or reviews study procedures manuals and other applicable study documents for use by the sites during the implementation of studies, as requested by the Clinical Project Manager
• Assists with development of project team organizational and tracking forms

Qualifications

• Bachelor’s degree, preferably in life sciences or nursing, with minimum 3 years CRA experience within the pharmaceutical or biotechnology industry. Sponsor experience an asset
• Previous study site coordinator role an asset
• Thorough knowledge and understanding of GCP/ICH required including an understanding of regulatory requirements
• Advanced site management and monitoring skills with experience of all types of visits (site selection, initiation, monitoring, and close out)
• Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint (preferred) Proficiency with filing systems and organizational tools
• Able to multi-task under limited direction and on own initiative
• Highly responsive and proactive and able to work remotely and with a remote team
• Ability to contribute creative yet practical solutions to problems
• Strong verbal and written communication and inter-personal skills. English speaking, Spanish is an asset
• Able to recommend and implement process improvements
• Ability to travel (including internationally) and work across cultures
• Ability to travel 60-70% of time, domestically or internationally, under rigorous travel schedules and conditions
• Ability to manage and prioritize workload effectively

Additional Information

All of your information will be kept confidential according to EEO guidelines.