Overview
IQVIA HCPN has several exciting positions in Italy for freelance CRAs.
Location: Italy Hours: around 20h per week Contract: Freelance Start: asap Duration: around 6 months, most work to be done until the end of this year.
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 the investigator recruitment process, performing site evaluation visits of potential investigators to evaluate the capability of the site to successfully manage and conduct the clinical study.
* Coordinate activities with the site and internal departments in preparation for the initiation of the study.
* Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF and EDC system; monitoring activities and study close-out activities.
* Assists in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
* Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
* Performs validation of source documentation as required by sponsor.
* Prepares monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs.
* Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor.
* Performs investigational product inventory.
* Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification and works with sites to resolve data queries and produce robust data.
* May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and / or Lead CRA.
* Serves as primary contact between IQVIA Biotech and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
* Assists with, and attends, Investigator Meetings for assigned studies.
* Attends study-related, company, departmental, and external meetings, as required.
* Ensures all study deliverables are completed per IQVIA Biotech and study timelines.
* Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
* Serves as mentor for junior CRAs and those new to the company and / or study.
Knowledge, Skills and Abilities
* Strong knowledge of clinical research process, including working knowledge of 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 express complex ideas to study personnel at research and clinical institutions.
* Able to form productive professional relationships both internally within own function, cross-functionally and externally with health care professionals.
* Able to handle several priorities within multiple, complex trials.
* Able to reason independently and recommend specific solutions in clinical settings.
* Able to work independently, prioritize, and work within a matrix team environment.
* Knowledge of current GCP / ICH guidelines applicable to the conduct of clinical research.
How to apply
If this role sounds of interest, please apply today!
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