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
· 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.