Clinical Research Associate

vor 5 Monaten

Rotkreuz, Schweiz ITech Consult Vollzeit

**Clinical Research Associate I (M/F/d) GCP / FDA / IVD directives / clinical studies / English**

**Project: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Clinical Research Associate I (M/F/d)**

**Background**: The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

**Tasks & Responsibilities**:

- Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements
- Validating product performance claims
- Supplying data for critical Regulatory submissions
- Defining the functional and clinical utility of investigational products
- Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders
- The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions
- Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout
- Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met
- Interfacing with cross functional staff to support post launch activities
- Reviewing cases with investigators to resolve discrepancies
- Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and Roche policies and procedures

**Must Haves**:

- Bachelor’s degree in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate
- Preferably experience in clinical research or laboratory research
- Min. 2 years of prior relevant experience
- Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines)
- Excellent oral and written communication skills in English
- Excellent planning, organizing, and interpersonal skills
- Ability to work independently, make sound decisions, and to analyze and solve problems
- Medical laboratory experience preferred
- Good therapeutic and protocol knowledge.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
- Organizational and problem-solving skills
- Effective time and financial management skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients

**Nice to have**:

- Experience in Pathology

**Reference Nr.: 923504TP**
**Role: Clinical Research Associate I (M/F/d)**
**Industrie: Pharma**
**Workplace: Rotkreuz**
**Pensum: 100%**
**Start: 02.08.24**
**Duration: 12++**
**Deadline: 02.07.24**

**If you are interested in this position, please send us your complete dossier via the link in this advertisement**. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com. Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

**Job Type**: 100%

Schedule:

- 8 Hour Shift

Work Location: On the road

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