Cra Ii / Sr Cra - Oncology - Home Based In Italy Milano

Cra Ii / Sr Cra - Oncology - Home Based In Italy
Milano
Lombardia, Milano

Description

**Clinical Research Associate II

Come discover what our 25, 000+ employees already know: work here matters everywhere.

We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.

As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world.

Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

**Why Syneos Health

- #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves.

Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.

- We believe our success is a direct result of the people who are driving it - you!

We value your dedication to care for our customers and patients, so we want to focus on taking care of you.

That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.

- We are continuously building the company we all want to work for and our customers want to work with.

Why?

Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

**Job responsibilities

- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.

Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.

Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):

- Assesses site processes

- Conducts Source Document Review of appropriate site source documents and medical records

- Verifies required clinical data entered in the case report form (CRF) is accurate and complete

- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines

- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture

- Verifies site compliance with electronic data capture requirements

- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.

Reconciles contents of the ISF with the Trial Master File (TMF).

Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.

Must be able to quickly adapt to changing priorities to achieve goals / targets.

- May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.

Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.

Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.

- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.

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**Qualifications

**What we are looking for

- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience

- Certified CRA according to the DM from 15 November 2011

- Minimum 1-year CRA work experience

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

- Must demonstrate good computer skills and be able to embrace new technologies

- Excellent communication, presentation and interpersonal skills

- Ability to manage required travel of up to 75% on a regular basis

**Get to know Syneos Health

We are the only full-service biopharmaceutical solutions company in the world.

That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most.