Vacancy expired!
Job Overview:Position location New York or New JerseyOncology Experience Strongly PreferredTravel up to 10%The Senior In-House Clinical Research Associate (Sr. IHCRA) is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to the Sr. IHCRA shall reflect their experience, and level of contribution which they can make to the project. The work will involve Clinical Operations activities which will be conducted in an office or home based setting for designated projects as well as some travel to conduct site visits or client or internal team meetings as needed. The Sr. IHCRA will be responsible for assisting with ensuring quality and integrity of data, and additional study related activities to support the efforts of study team members. Activities will be conducted in compliancewith Company or Sponsor SOPs, regulatory standards and applicable guidelines.Education/Qualifications:University or college degree, or certification in a related allied health profession from anappropriately accredited institution (e.g., nursing licensure). An equivalent amount ofexperience can be substituted as appropriate.Thorough knowledge of ICH-GCP guidelines, clinical trial process and understanding oflocal regulatory requirementsThorough knowledge of monitoring procedures processValid Driver's LicenseExperience:A minimum of 2+ years of independent Clinical Monitoring experience as a traveling CRAwith onsite monitoring experience or an equivalent combination of education andexperience to successfully perform the key responsibilities of the role.Ability to monitor study sites independently according to protocol monitoring guidelines,SOP, and local regulatory GuidelinesHave a full understanding of the Serious Adverse Event (SAE) reporting, processproduction of reports, narratives and follow up of SAEsAbility to work with minimal supervisionGood planning, organization and problem solving abilitiesGood communication skills, oral and writtenGood computer skillsWorks efficiently and effectively in a matrix environment
Vacancy expired!