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Strategically positioned at the heart of Europe, Stamford Consultants is a specialist recruitment company working within the Swiss and wider IT, Financial and Life Sciences sectors. - Everyday we bring together experienced and talented professionals seeking permanent and contract positions, and ambitious companies looking for key personnel with drive. - Our client is a CRO, located in the French speaking part of Switzerland, looking for a - Lead CRA/Principle CRA - Permanent - French speaking part of Switzerland - Key responsibilities:
- 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
Required skills:
- 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
Purpose: The Principal CRA participates in the planning, design and execution of clinical trials to ensure post approval studies are conducted according to the intent of the Sponsor´s projects while working collaboratively with internal and external project team members, including recruitment and training of the CRA´s as well as site identification and selection. Permanent - Ref.Nr.: 3991 If you are interested, please forward me your application by e-mail. KeywordsStamford Consultants AG - Mrs. Emel Buzluk - Friedensgasse 10 - CH-4143 Dornach -
emel@stamford-consultants.com -
www.stamford-consultants.com
