Oportunidades de Trabalho

Edição de Fevereiro/2018

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
  • Function in the role of Lead CRA for global studies, coordinating CRAs
  • Develop Clinical Monitoring Plan as requested
  • Conduct site visit trip report review and provide feedback and edits
  • Provide mentoring and guidance to less experienced CRAs and site staff when needed
  • Design study specific tools and templates as requested
  • Actively participate in study team and investigator meetings
  • Actively participate in bid defenses
  • Create and conduct training to study team members or colleagues as requested and appropriate
  • Work with Project Management to evaluate deliverables and study milestones
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
  • Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
  • Document site visit findings via written reports
  • Provide input into the design of protocols and CRFs as requested
  • Assess, monitor, and train study site staff on protocol adherence as required
  • Review study subject safety information and informed consent
  • Conduct source document verification for compliance, patient safety, and veracity of data
  • Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
  • Assist the site in maintenance of the Investigator Site File
  • Maintain regular communication with sites
  • Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
  • Ensure site compliance with IP receipt, accountability and return or destruction
  • Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate
  • Complete final site close out visit and report

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.

OTHER SKILLS AND ABILITIES:

  • Excellent oral and written communication skills
  • Excellent planning and organizational skills with effective time management
  • Excellent interpersonal skills
  • Demonstrate initiative and problem solving skills
  • Ability to lead and motivate assigned team (if applicable)
  • Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities
  • Extensive understanding of clinical research principles and process
  • Through understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
  • Through understanding of two to three therapeutic areas sufficient to function as a Lead CRA as appropriate
  • Thorough understanding of standard operating procedures
  • Proficiency in Microsoft Office
  • Proficiency with IxRS, EDC systems

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