Archive for October, 2011

Cambridge Semantic Web Monthly Meet-up

Friday, October 28th, 2011

Tuesday, November 8, 2011, 6:00 PM

MIT Stata Center
32 Vassar Street, Cambridge, MA (map)
4th floor, Kiva Conference Room, Stata Center, MIT

Overview of Semantic Web presented by Lee Feigenbaum, Co-founder Cambridge Semantics

This 90 minute talk will present a nuts-and-bolts introduction to many of the W3C Semantic Web technologies. We will motivate the introductions with use cases and examples, and we will also attempt to dispel some of the myths and some of the hype around the Semantic Web.

The intro will cover the following technologies:

  • RDF (data model)
  • RDFS (schema language)
  • OWL (ontology language)
  • SPARQL (query language)
  • RDFa (embedding RDF in HTML)

Please visit the following website about this event and RSVP if you are coming:

http://www.meetup.com/The-Cambridge-Semantic-Web-Meetup-Group/events/33224262/

Senior Clinical Trial Associate

Friday, October 28th, 2011

Job Description

POSITION SUMMARY:

Supports the Project Team by assisting in the administrative organization and management of projects ensuring compliance with Premier Research drug and/or device SOPs, Sponsor and ICH-GCP/ISO14155 requirements. This position may also involve general office administration tasks. The role involves high utilization of PC-based software packages for word processing, spreadsheets, and graphics.  Position will be office based.

PRIMARY JOB FUNCTIONS:

  • Manages administrative support and tasks for the Clinical Project Team, including but not limited to filing, faxing, memos, letters, photocopying and first-pass review of T&Es support for designated project team(s), as required
  • Site management communication for non-protocol related questions
  • Provides follow-up with Sponsor regarding study related issues as delegated by Project Manager or Clinical Manager
  • Prepares study documents at the direction and oversight of the Project Manager
  • Attends project team meetings, prepares meeting agendas and minutes, and maintains action item lists from meetings
  • Collects and tracks regulatory documents for submission to Central and/or Local IRB, Ethics Committees, Competent Authorities and/or other committees, as appropriate
  • Verifies IRB/EC approvals and collects and tracks other required regulatory documents; maintains study enrollment tracking and study status spreadsheets, as appropriate
  • Distributes study materials to investigator sites, Sponsors and team members, as needed
  • Prepares documents for and distributes various investigator, regulatory, operations, guidelines and training manuals
  • Assists in preparation for investigator and project launch meetings
  • Assists in preparation for and attends client meetings
  • Supports clinical monitoring staff for visit preparation regarding regulatory document tracking and other study file correspondences
  • Acts as the central contact for all members of the Clinical Project Team for the transmission, collation, tracking and filing of project documents, including but not limited to: site visit reports, status reports, CRFs, critical / regulatory documents, expense reports, financial reports, meeting minutes
  • Assists the Project Manager in facilitating verbal and written communication between Project Team members
  • Communicates with investigator sites for non-protocol related questions and possible query/monitoring related matters as delegated by Project/Clinical Manager
  • Creates and maintains Trial Master File according to Premier-Research Group or client SOPs
  • Where required, organises travel and logistical arrangements for client, investigator and internal meetings and attends as necessary; takes and distributes minutes
  • Arranges and attends Client and internal teleconferences or meetings; takes and distributes minutes
  • Assists with production and distribution of client status reports
  • Creates study documents, project tracking tools and other administrative tools as required by project team
  • Works with Project Manager to define study-specific process flow
  • Assists Sponsors, customers, or others with general project information
  • Gathers, compiles, and reports information relevant to departmental and project needs
  • Support the project team in liaising with third party vendors
  • Assist the project team in distribution of mailings, documents and other study materials to sites, IRB/Ethics Committees, Competent Authorities and others, as appropriate
  • Distributes necessary study budget / contract adjustment information to Project Team
  • Enters data into project databases and / or Excel spreadsheets in accordance with company standards and project specific guidelines
  • May assists with adverse event reporting, if required
  • May accompany CRAs on occasional site visits, if required
  • May conduct Study Close-Out Visits which require only regulatory document reconciliation
  • Assists CRAs in in-house monitoring activates such as CRF page separation, tracking and onward distribution, if required
  • Provides training and mentorship to newly hired or junior level Clinical Trial Associate, as requested
  • Contributes to SOP revisions and/or generation of related regulatory document management and study file maintenance
  • Supports the Start Up Manager in the feasibility process and in the submissions to Ethics Committees and Competent Authorities

OTHER RESPONSIBILITIES:

  • To update CV and Training records as necessary and make available for client review where appropriate
  • Remains alert for new business opportunities, network, and provides information to business development staff or manager
  • Communicates via electronic mail acknowledging and sending correspondence in a professional, timely manner
  • Responsible for the liaison with the Premier Research Archive, including management of the dispatch and retrieval of all documents to be archived
  • May be involved in general office logistical activities
  • May be responsible for line management and development of other CTAs
  • May support general office finance and administrative management
  • May assist in ensuring timely payment of invoices, cash flow, tax and social contribution payments
  • Performs other project related duties as assigned by the Project Manager
  • Performs other work-related duties as assigned

Required Skills

ESSENTIAL/ SKILL/EXPERIENCE REQUIREMENTS:

  • Ability to be productive and handle multiple tasks to meet deadlines in a dynamic environment is essential
  • Requires strong planning and organisational skills, verbal, written
  • Well developed communication skills, good at listening and sharing information with others
  • Ability to act on their own initiative
  • Collaborative approach to create an effective team and meet deadlines
  • Quality and detail oriented with high standards
  • Must be dependable and meet commitments
  • Applies clear and consistent performance standards and handles problems decisively and objectively
  • Strong computer skills in Word, Excel, and email are necessary
  • Fluent verbal and written English language is essential.
  • School certificate or equivalent required
  • Bachelors’ degree (BS, BA, or RN equivalent) in a biological- or science-related field preferred
  • 3 years minimum experience in clinical trials required
  • Some knowledge of FDA Guidance Documents/EU Directives/ICH Guidelines/ISO14155 regulations, drug/device development, and clinical monitoring procedures

Job Location

Quincy, MA US

Position Type

Full-Time/Regular

Contact

Interested candidates should submit their resume to: eugene.sidharto@premier-research.com

Boston University Receives Online Education Award from Sloan Consortium

Tuesday, October 18th, 2011

Boston University was recently honored with a national award for Excellence in Institution-Wide Online Education from the Sloan Consortium.

The Sloan Consortium (Sloan-C) is an association of institutions of higher education with the mission of improving quality, scale, and breadth of education through online learning. Sloan-C has been presenting awards since 2001. The 2010 award presentation took place on November 4th at the 16th Annual International Conference on Asynchronous Learning Networks, titled The Power of Online Learning: Stimulating New Possibilities in Orlando, FL.

Burks Oakley II, the Chair of the Sloan-C Awards Committee, described the 2010 award winners as demonstrating “exceptional leadership and real success in advancing online education.” In his award letter to Boston University, he stated that “the selection committee felt that Boston University’s online program was exemplary.”

Online programs at Boston University, including the online Master of Science in Computer Information Systems, are designed for busy working professionals, while maintaining the utmost academic quality and rigor. Students learn directly from world-class faculty who are experts in the field and also receive unprecedented support from course facilitators, administrators, and staff.

The online Master of Science in Computer Information Systems (MSCIS) program offers cutting-edge instruction and features the latest technologies in the marketplace. Students gain both technical and business competencies to aid them in becoming leaders in the IT profession. The innovative curriculum covers a variety of key topics including programming, networking, database management, project management, security, application development, management strategies, and more.

As evident with the recent Sloan-C award, Boston University provides an engaging online learning experience with the credibility that you need in a graduate degree. If you are looking to join the field of information technology or are ready for the next step in your current IT career, contact csinfo@bu.edu.

To read BU Today’s article about the Sloan-C award and online learning at BU, visit http://www.bu.edu/today/node/11648.

To read more about the Sloan-C awards, visit http://sloanconsortium.org/2010awards.