Cra/Clinical Research Associate - Certified Lazio

Cra/Clinical Research Associate - Certified
Roma
Lazio, Lazio

Labcorp Drug Development are helping to develop what could be the first pharmacological treatment able to help 3+ million severily ill hospitalized patients worldwideand we need you to contribute with your expertise_. _

**Labcorp Drug Development

With all the uncertainty in the world, your job stability should not be a concern.

Labcorp have supported the pharmaceutical industry develop more medicines worldwide than any other company, including the top 50 best-selling drugs on the market today.

But we are much more than a normal CRO:

- We are also the world´s biggest Central Lab, generating more clinical trial data than all other central laboratories combined

- LabCorp were the first in receiving FDA approval to perform COVID19 tests using an at-home collection kit.

Join us and see why Labcorp Drug Development are uniquely positioned to offer you not only a job, but a stable, long-term international career, and why more than 90% of the top 20 global pharmaceutical companies are repeat customers.

**What we have to offer**:

- work as part of a diverse and stable team

- in-depth onboarding, including personal support from your mentor

- flexible working hours and compensatory time off in lieu

- a permanent employment contract

- travel time = work time

- highly competitive compensation packages including local allowances and additional insurances

- regular, merit-based salary adjustments

- significant employer contributions to an attractive pension scheme

- excellent training and career development opportunities

- strong support from Line Management, your team and more than 20'000 colleagues worldwide

- the world's most renowned pharmaceutical companies and innovative biotech pioneers 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 careful source document review.

Monitor data for missing or implausible entries

- Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports

- Review progress of projects and initiate appropriate actions to achieve target objectives

- Interact with internal work groups to evaluate needs, resources and timelines

- Act as contact for clinical trial suppliers and other vendors as assigned

- Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

- Independently perform CRF reviews

- Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems

**Your profile**:

- Degree in a relevant field such as life sciences, pharmacology, biology, chemistry, health care, health management, (veterinary) medicine, nursing, etc.

; in lieu of the former, a completed vocational education or professional experience (e. g.

as study nurse, study coordinator. . . )

- Professional experience in a related function with a focus on independent site monitoring in Spain.

- Familiarity with applicable Spanish and international regulatory requirements such as ICH / GCP

- Computer literacy in Microsoft Office (Word, Excel, PowerPoint) and preferably in relevant software solutions for clinical trials, e. g.

eTMF (e. g.

Veeva Vault)

- Effective time management and organizational skills and a keen attention to detail

- Valid driver's license

- ** Excellent communication skills in business fluent Spanish and English - both spoken and written - are a must

**APPLY NOW

so we can tell you about the cookies & brownie days, the sense of humor and team support that permeate everything we do, how our managers constantly review study/site allocation to ensure workload balance or why you will not grow a stale career with us

**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.

**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 o