Clinical Research Assoicate II

JOB TITLE: Clinical Research Associate IIMUST HAVE HANDS ON CLINICAL EXPERIENCE!LOCATION: Rochester, New York,
RELOCATION BENEFITS: YesSTARTING BASE SALARY RANGE: $ 55,000 to $70,000 D.O.E.CITIZENSHIP: Must be a United States Citizen or Authorized to work for any employerBENEFIT PACKAGE: YesADVANCEMENT OPPORTUNITY: YesENVIRONMENT: Bio-Tech, Medical Devices
TRAVEL REQUIRED: Yes; Up to 25%EDUCATIONAL REQUIREMENTS: 4 year degree;
MINIMUM EXPERIENCE LEVEL RANGE: 3 -5 years
REQUIREMENTS
SPECIAL REQUIREMENTS:Candidate Must Have :
BA/BS
3-6 years experience as a CLINICAL RESEARCH ASSOCIATEMinimum 3 years as a study monitor
Knowledge and understanding of current regulatory issues related to Phase I-IV clinical researchBRIEF JOB DESCRIPTION: Manage and monitor all aspects of clinical study implementation in accordance with FDA regulations and ICH and GCP guidelines for clinical research studies and Standard Operating Procedures.Assume on-site and in-house monitoring responsibilities as needed and required by GCP.
Planning and creation of presentations of clinical research study information.Contribute to clinical research study design, quality assurance, data management, and reporting activities.
Identifies and evaluates issues related to the project and implements resolutions.
Provide input on departmental decisions related to process and procedures.
Participates in design and development of CRF’s.Participates in investigator recruitment and provide final recommendation.