Massachusetts General Hospital
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
Verify patient eligibility via chart abstraction and clinical analysis of case data
Collect and interpret data necessary for enrollment; register patients
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
• 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.
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.
Massachusetts General Hospital
Website : http://www.massgeneral.org/
Since 1811, Massachusetts General Hospital has been committed to delivering standard-setting medical care. Throughout the decades, the hospital has had a consistent commitment to advancing that care through pioneering research and educating future health care professionals.The third oldest general hospital in the United States and the oldest and largest hospital in New England, Mass General continues its tradition of excellence today. Mass General has consistently placed among the top hospitals on the U.S. News & World Report Best Hospitals Honor Roll since the survey began in 1990. In 2015, Mass General was named #1 in the nation based on our quality of care, patient safety and reputation in 16 clinical specialties. In 2013, Mass General was also redesignated a Magnet hospital, the highest honor for nursing excellence awarded by the American Nurses Credentialing Center.