Cra (All Levels), Hybrid, Fsp Client-dedicated

vor 2 Wochen

Schweiz Syneos Health Clinical Vollzeit

**Description**

**CRA (II or Sr CRA I), home-based, FSP client-dedicated, Switzerland - full-time, permanent role**

We are looking for a team member to join our FSP team as CRA, dedicated to one big global pharma.

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Discover what our 29,000 employees, across 110 countries already know: Work here matters everywhere.

**JOB SUMMARY**:
The Clinical Research Associate will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Requires guidance and oversight, while developing an understanding of the drug development and commercialization process.

**JOB RESPONSIBILITIES**:

- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- For the Clinical Monitoring/Site Management Plan (CMP/SMP):

- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete
- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
- Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture
- Verifies site compliance with electronic data capture requirements
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.
- May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:

- Site support throughout the study lifecycle from site identification through close-out
- Knowledge of local requirements for real world late phase study designs
- Chart Abstraction activities and data collection
- Collaboration with Sponsor affiliates, medical science liaisons and local country staff

**Qualifications**

**QUALIFICATION REQUIREMENTS**
- Min. Bachelor’s degree in Life Sciences (or equivalent combination of education, training and experience), but higher degrees (MSc, or PhD) are preferred
- Fluency in English, and German is mandatory. Italian is an additional advantage.
- Previous experience of min 2yrs with onsite independent monitoring is nee

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