Clinical Research Associate II

About the job

• The below statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
• Responsible for all aspects of site management as prescribed in the project plans
• General On-Site Monitoring Responsibilities
• Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
• Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
• Monitor data for missing or implausible data
• Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy
• Ensure audit readiness at the site level
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare accurate and timely trip reports
• Responsible for all aspects of registry management as prescribed in the project plans
• Undertake feasibility work when requested
• Participate in and follow up on Quality Control Visits (QC) when requested
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
• Might be requested to work in a client facing environment
• Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
• Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
• Assist with training, of new employees, e.g. co-monitoring
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
• Perform other duties as assigned by management

Experience:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND
• A minimum of 2 years of Clinical Monitoring experience.
• Oncology, hematology and vaccine experience required.
• Ability to work with minimal supervision.
• Have understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Good planning, organization, and problem solving abilities.
• Works efficiently and effectively in a matrix environment.

Qualifications

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.
• Thorough knowledge of monitoring procedures.
• Basic understanding of the clinical trial process.
• Fluent in local office language and in English, both written and verbal.