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CLINICAL RESEARCH COORD. II - BREAST ONCOLOGY - Cancer Center Protocol Office - (3112615)

If you are interested in being considered for this position, please visit www.mghcareers.org and apply for JOB ID #3112615.


GENERAL SUMMARY/ OVERVIEW STATEMENT:  
 
The Clinical Research Associate/Clinical Research Coordinator II (CRA/CRC II) works independently under general supervision to enroll eligible patients to clinical protocols and manage all aspects of data collection and submission for multiple cancer studies. The CRA/CRC II may require clinical skills such as phlebotomy, EKG, vital signs and laboratory responsibilities of blood, tissue and urine procurement, processing and shipping.

PRINCIPAL DUTIES AND RESPONSIBILITIES:    

This position represents a trained individual able to perform the following duties under general supervision by the Breast Group Project/Program Manager: 
  • Develop protocol specific flow charts, intake sheets, and other tools as needed to ensure protocol compliance and proper data acquisition
  • Schedule all protocol required evaluations
  • Obtain informed consent for minimal risk studies
  • Verify patient eligibility via chart abstraction and clinical analysis of case data
  • Collect and interpret data necessary for enrollment; register patients
  • Monitor and evaluate protocol compliance
  • Manage data collection via chart abstraction and submit data
  • Maintain research charts for all assigned studies and enrolled patients
  • Monitor and report adverse events as required by institutional/federal regulations
  • Administer Quality of Life and pain assessment evaluations to patients as needed
  • Coordinate, obtain, process, and ship all protocol required tissue samples
  • Prepare submission of protocol revisions and safety reports to the IRB
  • Prepare annual progress reports for IRB renewal of ongoing studies
  • Maintain study supplies and utilize study specific supplies as required
  • Organize monitoring visits as requested by sponsors and make data corrections as required by monitor
  • Resolve data discrepancies
  • Assess impact of new risk information on consent documents and revise appropriately

SKILLS/ABILITIES/COMPETENCIES REQUIRED: 
 
·        High degree of computer literacy
·        Ability to work independently and as a team member
·        Analytical skills and ability to resolve problems
·        Ability to interpret acceptability of data results
·        Working knowledge of data management programs
 
 
WORKING CONDITIONS: Describe the conditions in which the work is performed.
·        Duties will be performed in an office setting.
 

Qualifications

  
EDUCATION:  Specify minimum education and clearly indicate if preferred or required
·         BA/BS degree required

EXPERIENCE: Specify minimum creditable years of experience and clearly indicate if preferred or required
·    Minimum of 1-2 years of related experience or completion of the CCPO New Staff Orientation Program including completion of competency assessment.

Candidates without relevant experience will be hired as Clinical Research Coordinator I.