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Responsibilities

Receiving general direction from the Director of Project Manager and Co-Director of the Neurology Clinical Trials Unit (NCTU), the incumbent will assist NCTU Project Managers in overall project management of all multi-center clinical research activities managed by the NTCU. The incumbent will be responsible for assisting with all project management activities related to conducting multi-center clinical trials. The incumbent will be responsible for assisting the Project Managers in the day-to-day project management of multi-center clinical trials. The incumbent will also assist the Project Managers to generate reports to various committees, funding organizations, and regulatory offices for large multi-center clinical trials coordinated through the MGH Neurology Clinical Trial Unit. The incumbent may also be responsible for study monitoring and will travel to sites to perform study monitoring visits. The incumbent may be responsible for generating reports and maintaining records relating to monitoring assigned research studies. The incumbent will assist in site initiation, monitor study compliance and assist in additional study related projects as they arise.

Responsibilities include assisting Project Managers to:

1) develop protocols, including updates and amendments;

2) develop model consent forms and revisions;

3) prepare grant submissions;

4) to create case report form documents;

5) to obtain required documentation from study sites for the conduct of the studies, including biographical materials, other support, IRB approval letters, approved consent forms, and institutional support letters;

6) to draft and oversee the production, distribution and updates of the operations manual, which includes the detailed guidelines for study implementation at the sites;

7) to arrange the agendas and logistics of the annual training/review meetings of the investigators and coordinators, and for the meetings of the Steering and Safety Monitoring Committees, in concert with other meetings of the study investigators;

8) to field site questions and provide protocol clarifications on a daily basis via telephone, fax, e-mail and surface mail;

9) to monitor enrolling site performance for subject accession and data acquisition in accordance with the protocol and conveying this information to the study principal investigator as needed;

10) to document reportable events and other major concerns related to the studies and disseminating the information as needed to the PI, Medical Monitor and/or Steering Committee;

11) to assist the study Principal Investigator in implementing site monitoring plans;

12) to review reports for publication.

13) to oversee, with the study principal investigators, the development of the computerized database for each new study.

14) to inspect data forms for legibility, completeness and ambiguity.

15) to prepare reports for safety monitoring committee, as needed.

16) to prepare budget reports and check requests for site payments, as needed.

17) to monitor clinical sites, as needed, monitoring responsibilities include:

travel to sites to review case report forms and regulatory documents; travel time will vary with phase of study; estimated travel is 20 to 80%

ensuring site compliance with all federal regulations and Good Clinical Practice Guidelines

inspecting source documentation and CRFs to verify accuracy, legibility, and completeness

acquiring detailed knowledge of assigned studies

follow all NCTU monitoring SOP guidelines for monitoring of clinical studies

18) Accept responsibilities forspecial projects, as requested

Qualifications

Bachelors degree required. Good working knowledge of federal regulations and ICH/GCP Guidelines required. One to two years project