Zurück zur Suche.Stamford Consultants - English/German/Italian Clinical Research Associate
| Beschäftigungstyp: | Permanent |
| Standort: | Lausanne - Vaud, Switzerland, 1200 |
| Gehalt: | 90'000 CHF |
| Sprachen: | Englisch, Deutsch, Italienisch |
| Erforderlichen Sprachen: | 2 |
Details für die Anzeigenschaltung
- Name:Stamford Consultants
- Veröffentlichung:13-02-2012
- Code:VR/04224
Task
- Participates in recruiting and contracting of CRA´s
- For selected studies, participates in the site/investigator selection system/process
- Performs pre-study visits, provides CRA´s with clear objectives concerning site selection
- Coordinates sites including start-up activities, covering all European activities and matched time-zones
- Tracks all Ethic Approvals and all CRA activities
- Reviews protocol and assists with case report form design
- Fulfills CRA I tasks such as monitoring studies within Switzerland
- Develops study monitoring plans for assigned studies
- Independently conducts all types of monitor visits, including but not limited to qualifying site assessments, initiation, interim and closeout
- Documents site-specific monitoring visit plans and reports
- For selected studies, participates in completion of study related documents, including informed consent form, template source documents, training manuals, regulatory binder and other resource materials
- Assists with IRB/ethic committee submission process (both central and local submissions)
- Assists in investigator and study staff training, including global CRA contractors when needed
- Tracks and reports study site progress
- Mentors less experienced Clinical Research Associates
- Attends and participates in investigator and study coordinator meetings
- Collaborates with the Site Management Team to provide centralized site support, communication and coordination, to assure accurate and timely completion of all contracted activities
- Establishes and maintains communication with clinical sites, in-house and regional clinical research associates
- For selected studies, acts as Lead CRA, by coordinating resources, trainings and CRA activities among a team of remote CRA resources
Profile
- Bachelors Degree; Degree in science/health related field preferred
- At least 3 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 2 years of independent clinical monitoring required
- Approximately 20% travel will be required, to attend Investigator Meetings, Site Visits, Professional Conferences
- Participates in recruiting and contracting of CRA´s
- For selected studies, participates in the site/investigator selection system/process
- Performs pre-study visits, provides CRA´s with clear objectives concerning site selection
- Coordinates sites including start-up activities, covering all European activities and matched time-zones
- Tracks all Ethic Approvals and all CRA activities
- Reviews protocol and assists with case report form design
- Fulfills CRA I tasks such as monitoring studies within Switzerland
- Develops study monitoring plans for assigned studies
- Independently conducts all types of monitor visits, including but not limited to qualifying site assessments, initiation, interim and closeout
- Documents site-specific monitoring visit plans and reports
- For selected studies, participates in completion of study related documents, including informed consent form, template source documents, training manuals, regulatory binder and other resource materials
- Assists with IRB/ethic committee submission process (both central and local submissions)
- Assists in investigator and study staff training, including global CRA contractors when needed
- Tracks and reports study site progress
- Mentors less experienced Clinical Research Associates
- Attends and participates in investigator and study coordinator meetings
- Collaborates with the Site Management Team to provide centralized site support, communication and coordination, to assure accurate and timely completion of all contracted activities
- Establishes and maintains communication with clinical sites, in-house and regional clinical research associates
- For selected studies, acts as Lead CRA, by coordinating resources, trainings and CRA activities among a team of remote CRA resources
Profile
- Bachelors Degree; Degree in science/health related field preferred
- At least 3 years clinical research experience required in a pharmaceutical, biotech or CRO setting with a minimum of 2 years of independent clinical monitoring required
- Approximately 20% travel will be required, to attend Investigator Meetings, Site Visits, Professional Conferences
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