Clinical Research Associate - freelance

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