Zurück zur Suche.Stamford Consultants - English - LEAD CRA
| Beschäftigungstyp: | Permanent |
| Standort: | Lausanne - Vaud, Switzerland, 1200 |
| Gehalt: | 110'000 CHF |
| Sprachen: | Englisch |
| Erforderlichen Sprachen: | 1 |
Details für die Anzeigenschaltung
- Name:Stamford Consultants
- Veröffentlichung:13-02-2012
- Code:VR/03991
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
Due to the nature of this position, the recruiter has requested to restrict applications by location. Only candidates in Europe (EEA) may apply.
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