Job Description

The Clinical Research Associate II (CRA II) is responsible and accountable for site monitoring and site management. Has responsibility for clinical studies according to Company, and/or Sponsor Standard Operating Procedures, and local regulatory guidelines. Assures the implementation of project plans, as assigned. Act in the project role of a Local Project Coordinator or Lead CRA as assigned.

Essential Job Duties:
\xef\x82\xa8 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.
\xef\x82\xa8 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
\xef\x82\xa8 Responsible for all aspects of site management as prescribed in the project plans
\xef\x82\xa8 General On-Site Monitoring Responsibilities
\xef\x82\xa8 Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
\xef\x82\xa8 Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
\xef\x82\xa8 Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
\xef\x82\xa8 Monitor data for missing or implausible data
\xef\x82\xa8 Ensure the resources of the Sponsor and Labcorp 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 Labcorp travel policy
\xef\x82\xa8 Ensure audit readiness at the site level
\xef\x82\xa8 Travel, including air travel, may be required and is an essential function of the job.
\xef\x82\xa8 Prepare accurate and timely trip reports
\xef\x82\xa8 Responsible for all aspects of registry management as prescribed in the project plans
\xef\x82\xa8 Undertake feasibility work when requested
\xef\x82\xa8 Participate in and follow up on Quality Control Visits (QC) when requested
\xef\x82\xa8 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
\xef\x82\xa8 Might be requested to work in a client facing environment
\xef\x82\xa8 Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
\xef\x82\xa8 Independently perform CRF review; query generation and resolution against established data review guidelines on Labcorp or client data management systems as assigned by management
\xef\x82\xa8 Assist with training, of new employees, e.g. co-monitoring
\xef\x82\xa8 Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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