Associate Clinical Research Associate Lazio

Associate Clinical Research Associate
Roma
Lazio, Lazio

We are a research-driven biopharmaceutical company.

Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world.

We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are looking for an Ass.

Clinical Research Associate to join our Clinical Research Monitor Team.

With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents

Gains an in-depth understanding of the study protocol and related procedures

Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready

Participates & provides inputs on site selection and validation activities

Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased; Subjects' right, safety and well-being are protected

Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner

Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out

Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance

Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines

Supports audit/inspection activities as needed

Performs co-monitoring where appropriate.

**Experience Requirements**:

Min.

2 years of clinical research experience.

Related CR experience may include Clinical Trial Assistant, Study Coordinator, Regulatory CTC or similar.

**Educational Requirements**:

B. A. /B. S.

with strong emphasis in science and/or biology

**CORE Competency Expectations**:

Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information.

Developing ability to present technical information with support.

Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

Good understanding of Global, Country/Regional CRA Guidelines and ability to work within these guidelines.

Hands on knowledge of Good Documentation Practices

Developing skills in Site Management including management of site performance and patient recruitment

Developing level of monitoring skill and independent professional judgment.

Works with high quality and compliance mindset.

Capable of managing complex issues, solution-oriented approach.

Ability to perform root cause analysis and implement preventative and corrective action

Who we are

We are known as Merck & Co. , Inc. , Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else.

For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases.

Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world.

Here, you have that opportunity.

You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time.

Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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**Employee Status**:

Regular

**Reloca