Job Details: Italian Clinical Trial Associate


JobsIreland
Jervis Street
Dublin 1
Italian Clinical Trial Associate
Clinical Trial Associate

Location: Cork, Ireland

Our client is a global leading pharmaceutical company who are
searching for a Clinical Trial Associate to join a brand new exciting
project.

The Clinical Trial Capabilities Team provides clinical trial
capabilities in support of clinical development. The Associate is
accountable to ensure the investigator sites meet requirements to
enrol study participants into clinical trials and support ongoing
activities during site maintenance and closeout. The Associate is
responsible for obtaining clinical trial authorizations and ethical
approvals, execution of the budget and contract, and activities
related to clinical finance, records management and site training.

The Associate will ensure inspection readiness through a complete,
accurate and readily available Trial Master File. Additional local
responsibilities may be required as needed/appropriate for the local
geography and/or to cover regional differences.

Responsibilities

* Initiate investigator site activities, including collection and
submission of regulatory documents, customization and negotiation of
informed consent documents, serve as the point of contact for a
site&#**Apply on the website**;s ERB and Competent Authority
(CA)(where applicable), communicate and negotiate budgets with site
personnel and internal teams, negotiate and obtain fully-executed
contract, track and ensure site compliance to required training, and
effectively drive timelines aligned with company priorities

* Communicate directly with sites to enable start-up and maintain an
active collaboration with sites during maintenance and close-out

* Identify, communicate, and resolve issues

* Ensure country specific regulatory and data privacy requirements are
incorporated into submission documents and any other documents/systems

* Leverage previous site / review board engagements to efficiently
drive new work

* Populate internal systems to ensure accuracy of trial / site
performance

* Understand and comply with procurements, legal, financial
requirements and procedures

* Populate Trial Master Files and libraries for future reference

* Provide feedback and shared learning for continuous improvement

* Leverage trial prioritization

* Anticipate and monitor dynamically changing priorities

Basic Qualifications

Bachelor&#**Apply on the website**;s degree preferably in a scientific
or health related field, two years clinical research experience or
relevant experience preferred

Understanding of overall clinical development paradigm and the
importance of efficient site initiation

Applied knowledge of project management processes and skills

Appreciation of / experience in compliance-driven environment

Ability to learn and comply with financial and legal guidelines and
policies (budget and contract)

Additional Skills/Preferences

Effective communication, negotiation, and problem solving skills

Fluent in English and Italian

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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