Job Description

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 cancer studies.

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
* Verify patient eligibility via chart abstraction and clinical analysis of case data
* 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
* 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
* Resolve data discrepancies
* Assess impact of new risk information on consent documents and revise appropriately
* Schedule all protocol required evaluations (physical exams, radiology, labs, etc.)
* Coordinate patient appointments with physicians, nurses and all test areas
* In cooperation with the SPL (Sample Processing Lab) coordinate, obtain (e.g. draw bloods), process (e.g. spin/separate/freeze samples), and ship (e.g. utilization of specific packaging and ensuring proper handling and shipping of samples) all protocol required tissue samples
* Obtain vital signs, EKG as indicated, coordinate clinical safety laboratory specimen draws and ensure timely results are available to healthcare providers

QUALIFICATIONS:

EDUCATION:

* BA/BS degree required

EXPERIENCE:

* 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.

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

Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged.
EEO Statement
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. Applications from protected veterans and individuals with disabilities are strongly encouraged