Bulfinch Temps is looking for a Clinical Research Coordinator II to work in the Cancer Center Protocol Office at MGH set to start in May until August. This position is 40 hours per week Mon-Fri 8A-430P. Please note that this position is temporary and does not offer benefits.
GENERAL SUMMARY/ OVERVIEW STATEMENT:
The Clinical Research Associate II (CRA 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.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
This position represents a trained individual able to perform the following duties under general supervision by the Project/Program Manager:
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
Prepare submission of protocol revisions and safety reports to the IRB
Prepare annual progress reports for IRB renewal of ongoing studies
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
Ability to work independently and as a team member
High degree of computer literacy
Analytical skills and ability to resolve problems
Ability to interpret acceptability of data results
Working knowledge of data management program
BA/BS degree required
Minimum of 1-2 years of related experience or completion of the CCPO New Staff Orientation program including completion of competency assessment
Duties will be performed in an office setting.