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Subject: Clinical Research Associate for our end client. Job Location: Cambridge, MA

Rita Dhanavade posted a job: Clinical Research Associate for our end client. Job Location: Cambridge, MA

"BereanGroup is looking for a Clinical Research Associate for our end client. Job Location: Cambridge, MA Job Duration: 6 months Citizenship / Work Authorization: Must be US Citizen or Perm Resident Only Duties and Responsibilities • Responsible for operational component of IIS • Participates in cross-functional IIS review committee (IRC) meetings • Works with Medical Science Liaisons (MSLs) and principal investigator and his/her staff to facilitate and oversee the process of study activation for approved Letters of Intent (LOIs) • Coordinates and manages review of draft protocol, final protocol and primary site informed consent form, and, if applicable, investigator IND submission • Communicates with MSL and principal investigator and his/her staff throughout the duration of the study regarding enrollment, final study report and study closeout • Provides regular updates to IIS Director, IIS Program Manager and Global Medical Affairs (GMA) Medical Director on the overall clinical strategic operations plan for studies including timelines, key deliverables and key operational issues • Reviews and comments on proposed trial budgets • Responsible for reconciling study budgets as needed with sites at study closure • Drafts budget/payment terms for applicable contract appendices • Works with MSLs and investigators to manage and oversee study timelines • Reviews and submits clinical trial material orders • Submits and maintains IIS data and milestones in the IIS database Participates in cross-functional teams in a matrix environment Qualifications • BA/BS/RN/RPh (preferably in healthcare/science field) with 3+ years of progressive experience in clinical operations. Experience in IIS program management a plus. • Thorough understanding of FDA, ICH, and GCP guidelines as well as a thorough understanding of cross-functional clinical processes within GMA, Pharmacovigilance, Legal, Contracts, Clinical Trials Materials Management, and Regulatory Affairs. For More Job description and to apply click on the links below: [ http://www.bereangroup.com/jobInfo.do?jobId=115896 ] You can also mail your resume at resumes@bereangroup.com and rita.d@bereangroup.com with the job #115896 in the subject line. Applications without the job number may not be attended to. International candidates please excuse. Citizenship / Work Authorization: Must be US Citizen or Perm Resident Only"

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