Clinical Research Associate 2 Lazio

Clinical Research Associate 2
Roma
Lazio, Lazio

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 infonned 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 Covance 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 Covance travel policy

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

Recruitment of potential investigators, preparation ofEC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as

instructed by supervisor

Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives

and follow up of SAEs

Independently perform CRF review; query generation and resolution against established data review guidelines on Covance 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

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