Clinical Research Associate I Milano

Clinical Research Associate I
Milano
Lombardia, Milano

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, with or without guidance; liaise with vendors; and other duties, as assigned

- Responsible for aspects of registry 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

- Travel, including air travel, may be required and is an essential function of the job.

- Prepare accurate and timely trip reports

- Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp or client data management systems, as assigned by management

- Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management

- Provide coverage for clinical contact telephone lines, as required

- Update, track and maintain study-specific trial management tools/systems

- Generate and track drug shipments and supplies, as needed

- Track and follow-up on serious adverse events as assigned

- Implement study-specific communication plan as assigned

- Attend investigators' meetings, project team meetings and teleconferences, as needed

- Assist Senior CRA in managing investigator site budgets

- Perform other duties as assigned by management

**Labcorp is proud to be an Equal Opportunity Employer**:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.