Clinical Research Associate - freelance

IQVIA; Italia; Remoto; EUR 30.000 - 50.000; Part-time

Descrizione del lavoro

A leading clinical research organization in Italy is looking for freelance Clinical Research Associates (CRAs) to participate in clinical trials. Candidates should have at least 2 years of CRA experience and strong oncology knowledge. This position requires excellent communication skills and the ability to manage multiple priorities. Responsibilities include overseeing clinical investigations and ensuring compliance with Good Clinical Practices.

Competenze

• Minimum of 2 years experience as a CRA.
• Experience in monitoring and/or coordinating clinical trials required.
• Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

Mansioni

• Participates in the preparation and execution of Phase I-IV clinical trials.
• Oversees the progress of clinical investigations by conducting site evaluation and visits.
• Documents accountability and performs investigational product inventory.

Conoscenze

Strong knowledge of the clinical research process

Excellent written and verbal communication skills

Ability to manage multiple priorities

Ability to reason independently

Oncology experience

Descrizione del lavoro

Overview

IQVIA HCPN has several exciting positions in Italy for freelance CRAs.

Hours: around 20h per week

Contract: Freelance

Start: asap

Responsibilities

• Participates in the preparation and execution of Phase I-IV clinical trials.
• Oversees the progress of clinical investigations by conducting site evaluation, initiation, and interim close out visits to sites.
• Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.
• Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.
• Participates in investigator recruitment processes, performing site evaluation visits to assess site capability.
• Coordinates activities with the site and internal departments in preparation for study initiation; performs initiation activities, trains site personnel on protocol, regulatory issues, study procedures, eCRF/EDC, monitoring and close-out activities.
• Assists in resolving issues to ensure compliance with site file audits in conjunction with ISS.
• Ensures adherence to Good Clinical Practices and investigator integrity, performs source data validation as required, and prepares monitoring reports and letters per IQVIA Biotech SOP timelines.
• Documents accountability, stability and storage conditions of clinical trial materials; performs investigational product inventory.
• Assesses quality and integrity of clinical data through in-house review of electronic CRF data and on-site source verification; resolves data queries with sites to produce robust data.
• Assists with review of protocols, eCRFs, study manuals and related documents as requested by the Clinical Trial Manager or Lead CRA.
• Serves as primary contact between IQVIA Biotech and investigator; coordinates correspondence; ensures timely transmission of clinical data and reports to the study site.
• Assists with, and attends, Investigator Meetings for assigned studies; attends study-related meetings as required.
• Ensures all study deliverables are completed per IQVIA Biotech and study timelines.

Knowledge, Skills and Abilities

• Strong knowledge of the clinical research process, including all functional areas of clinical trials and medical terminology.
• Minimum of 2 years experience as a CRA.
• Experience in monitoring and/or coordinating clinical trials required.
• Oncology experience needed
• Excellent written and verbal communication skills to convey complex ideas to study personnel at research and clinical institutions.
• Ability to form productive professional relationships internally and externally with health care professionals.
• Ability to manage multiple priorities across complex trials; work independently and within a matrix team environment.
• Ability to reason independently and propose solutions in clinical settings.
• Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research.

If this role sounds of interest, please apply today!

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Administrative, Health Care Provider, and Research

Industries

• Research Services