**Clinical Research Associate 2 / CRA 2 - Multi
- Sponsor Team**
Location: Italy
A formula for clinical innovation: Labcorp Drug Development.
With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas - improving health and lives every day.
**What you can expect from us**:
- flexible working hours, capped overtime and compensatory time off in lieu;
- 100% home-based, permanent employment contract with Labcorp Drug Development;
- travel time = work time;
- highly competitive compensation packages;
- subsidized meals and transportation allowances;
- regular, merit-based salary adjustments;
- significant employer contribution to an attractive pension scheme;
- extensive insurance coverage, including medical, life, short as well as permanent disability and accidents;
- excellent training and career development opportunities as well as support with furthering your education;
- strong support from Line Management and more than 20'000 colleagues worldwide;
- the world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years.
**Your responsibilities**:
- Own all aspects of site management as described in the project plans;
- Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study;
- Protect 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 diligently reviewing source documents.
Monitor data for missing or implausible entries;
- Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; submit accurate and timely trip reports;
- Review progress of projects and initiate appropriate actions to achieve target objectives;
- Act as a primary contact for clinical trial suppliers and other vendors;
- Own the entire process of Serious Adverse Event (SAE) reporting;
- Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems.
**Education**:
- Degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, etc.
- In lieu of the above, a valid certification in health / life sciences by an accredited institute.
**Experience**:
- Solid independent monitoring experience in Italy as CRA, with a focus on complex clinical trials (phases II and III);
- Proven experience in a variety of therapeutic areas, preferably including oncology;
- Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the Italian regulatory authorities landscape;
- IT-literate, including Microsoft Word, Excel, PowerPoint, and preferably eTMF solutions such as Veeva Vault;
- Effective time management and organizational skills and a keen attention to detail;
- Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders.
**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.
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