Clinical Research Associate - DOC by lbs18738

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									                              Synairgen Research Limited

                                     Job Description


JOB TITLE:                     Clinical Research Associate II


CURRENT HOURS:                 37.5 hours


REPORTING TO:                  Senior Clinical Research Associate


JOB PURPOSE:                   To carry out and complete Synairgen’s clinical studies
                               and to assist and support the Senior/Lead Clinical
                               Research Associate and to work effectively as part of a
                               team.


LOCATION:                      Southampton, Field Based


RESPONSIBILITIES


PROFESSIONAL:
   Performing clinical trial initiation, monitoring and close out activities while
    adhering to all applicable regulatory and Standard Operating Procedures (SOPs)
    and Study Specific Operating Procedures, this may consist but is not limited to
    the following tasks:
       o   To take full responsibility for co-ordinating with the ethics committee and
           research & development committees to set up clinical trial sites and assist
           less experienced CRA’s;
       o   To locate and assess the suitability of facilities at a study centre;
       o   To training site staff to industry standards;
       o   To monitor the trial throughout its duration, including visits to the study
           centres on a regular basis;
       o   To verify that data entered on to the CRFs is consistent with patient
           clinical notes (SDV);
       o   To collect completed CRF pages;
       o   To write visit reports;
       o   To maintain contact with centres via phone calls and emails;
       o   To file and collate trial documentation and reports;
       o   To ensure supplies are provided to sites;
       o   To ensure all unused trial supplies are accounted for;
       o   To archive study documentation and correspondence;



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                            Synairgen Research Limited

                                  Job Description
      o   To communicate effectively with site personnel, including the Principal
          Investigator, and Synairgen management to relay protocol/study
          deviations and ensure timely implementation of corrective actions.
    Present at Investigator Meetings as appropriate.
    To act as a member of the project team and contribute towards the efficient
     management of trials.
    To oversee all aspects of study site management.
    To ensure high quality data, that results in consistently low queries and in good
     Quality Assurance reports.
    To undertake feasibility work when required.
    To assist the Lead CRA in ensuring trackers are kept up to date as appropriate.
    To assist the Lead CRA in writing project manuals/plans as appropriate.
    To assist the Lead CRA in developing project tools as appropriate.
    To assist in sourcing and communicating effectively with specialist consultants
     as appropriate.
    To assist in negotiating study budgets as appropriate.


KEY COMPETENCIES


    Excellent attention to detail and established organisational skills.
    Demonstrate flexibility, professionalism and good interpersonal skills.
    Excellent knowledge of ICH-GCP, relevant SOP’s and regulatory guidance.
    Able to solve project related problems.
    Ability to prioritise workload and meet deadlines.
    Self motivated, ability to work and plan independently as well as in a team.


MANAGEMENT:

    To perform co-monitoring visits with a CRA I/CTA for training purposes where
     appropriate.
    To resolve queries of CRF data with study site personnel.
    To act as mentor for a CRA I/CTA.


EDUCATION AND DEVELOPMENT:
    To acquire and demonstrate knowledge and skills, following the Company’s
     SOPs, applicable to the clinical trials.
    To attend statutory training days and study days.


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                            Synairgen Research Limited

                                 Job Description
    To comply with the SUHT Infection control, Risk Management, Fire policy and
     procedures and the Health and Safety Policy.


OTHER:
    To assist with Company quality assurance and audit.
    To comply fully with the 1988 Data Protection Act. It is the responsibility of
     each member of staff to ensure that all computerised/manual personal
     information relating to subjects or other members of staff, to which she/he has
     access in the course of employment, is regarded as strictly confidential.




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