Clinical Research Associate

3 settimane fa

Milano, Italia Talent Source A tempo pieno

Description:
**Location**: Milan, Italy - Hybrid based

**Schedule**: Full-time, permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds.

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a
- **Clinical Research Associate** to join our client-based team. This is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. It improves patients' health and quality of life and provides them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in oncology, neurosciences, and rare diseases.

CRA under the oversight of the CRM manages and monitors clinical trials of competence, local and/or international, of phase II, III, or IV, in different therapeutic areas, according to ICH-GCP, company SOPs and Italian regulations related to the clinical research and observational studies, to ensure quality objectives, compliance with the deadlines and achievement of the target planned for enrolled patients. Being responsible for all activities conducted in competent investigational sites, as well as, the relationship with the doctors and sites staff, involved in the conduction of clinical trials

**Main Job Tasks and Responsibilities**:

- Ensures an adequate level of knowledge of the protocol and relevant amendments, CRF, and all documents and/or information systems related to the clinical trial for him/herself attending all related training and meetings.
- Ensures an adequate level of knowledge of the protocol and relevant amendments, CRF, and all documents and/or information systems related to the clinical trial for the site staff involved in the study conduction. Prepares and shows presentations on specific topics upon request.
- Provides support for the preparation of site-specific study documents to be submitted to the IRBs, cooperating with the Medical & Clinical Officer.
- Arranges the submission package and manage the shipment to the related contacts.
- Cooperates with the Medical & Clinical Officer for follow-up activities until the IRBs approvals have been collected.
- Cooperates with the Medical & Clinical Officer for site payments.
- Participates in the study feasibility and site selection phase, performing the Pre-study visits.
- Plans and arranges the Site Initiation Visits based on the ethical administrative process of each site allocated and the study timelines.
- Performs routine monitoring activities in the office and on-site, according to the monitoring plan and study instructions.
- Plans and arranges the Close-out Visits to close all activities and issues pending at the end of the study, according to the study timelines.
- At any step of monitoring activities, proactively identify potential issues in the study conduction at his/her competence sites, including protocol deviations and GCP noncompliance, communicate them to the CRM and to other relevant business functions according to the type of issue detected, in a timely manner, and proactively propose appropriate solutions to resolve the issue.
- Maintains regular telephone contacts with investigational sites for the management of pending issues and to verify the study progress, with particular attention to the patient enrollment performances, the investigational drug re-supply, and to safety aspects.
- Guarantees the accuracy, completeness, and regular update of the company clinical trial database.
- Participates in the preparation and conduction of on sites audits and/or regulatory inspections with the Clinical Research Manager.
- Participates in Investigator Meetings.
- Arranges and keep updated the study document archive, for each study allocated, for his/her competence investigational sites, in the office, and on-site.
- Performs regular reviews of documents in order to ensure their accuracy and completeness.
- Performs documents translation according to Corporate request

**Education and Experience**:

- Educated to post-graduate degree level in life science
- At least 3 years of monitoring experience according to ICH-GCP, study guidelines, and applicable regulations in the international pharmaceutical field.
- Strong working knowledge of the science topics (e.g.: site monitoring of international interventional clinical trials and observational studies, very good knowledge of trial documentation, and medical terminology).
- Minimum requirement of at least 1 year of monitoring experience and/or a previous experience as a Clinical Trial Assistant.

**Specific Role Requirements and Skills**:

- Excellent fluency in the English language written/spoken essential to the function
- Knowledge and management of clinical trial documentation and requirements
- Knowledge of electronic tools for data collection eCRF
- Good knowledge of Microso

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