Clinical Research Associate II with 3+ years for international CRO

September 8, 2013 by · Comments Off on Clinical Research Associate II with 3+ years for international CRO
Filed under: Clinical Research 

International CRO:
We offer a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. Our services span
the entire lifecycle of product development and can be adapted to suit small local trials or large global programs.

Job Title:
CRA II office based in Rome or home-based

Job description:
Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.

Responsibilities:

Tasks may include but are not limited to:

  • Perform feasibility studies for potential sites as requested
  • Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.) Read more

Clinical Trial Assistant – fast growing international CRO – Office based Milan center

July 12, 2013 by · Comments Off on Clinical Trial Assistant – fast growing international CRO – Office based Milan center
Filed under: Clinical Research 

Clinical Trial Assistant role available in a fast growing international CRO, Office based Milan center

Associate will provide administrative support to clinical projects under direction of line manager and other designated clinical team members. Assists with general administrative functions as required.

 

Key responsibilities:

  • Assist the Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. Read more

Clinical Operations Manager Italy – CRAs Manager for International CRO

June 9, 2013 by · Comments Off on Clinical Operations Manager Italy – CRAs Manager for International CRO
Filed under: Clinical Research 

International CRO:
We offer a broad range of specialised services to assist pharmaceutical, biotechnology and medical device companies to bring new drugs and devices to market faster. Our services span
the entire lifecycle of product development and can be adapted to suit small local trials or large global programs.

Job Title:
Clinical Operations Manager Italy – CRAs Manager

Job description:
To manage, under the direction of the Vice President of Clinical Operations, the standardization, implementation and development of company-wide tools, training and processes for Clinical Operation Department.

RESPONSIBILITIES:

Tasks may include but are not limited to:

  •  To work with the Clinical Operations Managers and Training Department to design CRA training materials and programs
  • To work with company departments in the design and application of standardized tools and templates
  • To develop co-monitoring procedures and standards
  • To aid in the development and writing of departmental and company-wide newsletters
  • To write and update Clinops Department company-wide SOPs, or to delegate the writing of SOPs to a representative
  • To coordinate efforts between the Project Management and Site Management Offices to reduce duplication of efforts and standardization of processes
  • To actively participate in company meetings
  • To coordinate, with Human Resources, resourcing procedures and metrics
  • To coordinate, with Quality Assurance, training opportunities identified in CAPA information
  • To interact with other departments of CRO on procedural issues
  • To improve timesheet training and tools
  • To track company-wide metrics and assessments

Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

 

Requirements:

  • At least 2/3 years of experience in people management (within a CRO or global pharmaceutical company)
  • CRAs recruitment/hiring experience
  • Previous experience as CRA is mandatory (4+ years)
  • Office based in Rome would be preferable (alternatively home based)
  • Fluent in the local languages of the countries under responsibilities and fluent in both spoken and written English
  • Available asap

How to apply:
Please send your resume to cv.crasecrets [at] crasecrets.com with subject “CRA Manager – CS 130609″