Clinical Research Associate Ii

hace 3 semanas

Barcelona, España Labcorp A tiempo completo

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 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

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 Labcorp 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

**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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