Assistant Cra

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

We are looking for an **Assistant CRA who will be home based in Switzerland**. You will perform remote site management and monitoring activities on assigned project(s) in accordance with FDA and/or local regulations and guidelines, ICH GCPs and company's procedural documents by reviewing study data from various sources remotely. You will contact study sites to collect study documentation, resolve issues and request outstanding information. May be assigned limited site contact activities during study start-up, site management, recruitment and close out phases.

**Key responsibilities**:
According to the specific role (Central or Local) you may coordinate, oversee and complete assigned trial activities detailed on the task matrix, including but not limited to the following:

- Completes and documents study-specific training
- Orients and trains on any Clinical Research Group (CRG)/study-specific systems
- Provides in-house support during pre-study assessments and with pre-study asssessment waivers, as agreed for project
- Supports to customize Site ICF with site contact details, as needed
- Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments
- Verifies document collection and RCR submission status; updates site EDL and verifies site information
- Reviews patient facing materials and review translations, as directed
- Supports site staff with the vendor related qualification process, where applicable
- Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study
- Provides support to follow-up on site staff training, as appplicable
- Coordinates and supports logistics for IM attendance, as directed
- Supports maintenance of vendor trackers, as directed
- Coordinates study/site supply management during pre-activation and subsequent course of the study
- Supports Essential Document collection, review and updating in systems, as applicable
- Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed
- Supports ongoing remote review of centralized monitoring tools, as directed
- Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period
- Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable
- Verifies document collection status in CRG systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
- May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner

**Education and Experience**:

- Bachelor's degree, preferably in a life science related field or equivalent and relevant formal academic / vocational qualification
- Typically, prior clinical research experience (0-1 year) and/or knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities. In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management, medical terminology, medical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered
- Individuals who aspire to advance into a CRA role

**Knowledge, Skills and Abilities**:

- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and company's procedural documents
- Ability to successfully complete co