Clinical Research Associate II-Cancer Center Protocol Office

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POST DATE 8/31/2019
END DATE 2/7/2020

Massachusetts General Hospital(MGH) Boston, MA

Location
Boston, MA
AJE Ref #
584729956
Job Classification
Full Time
Job Type
Regular
Company Ref #
3096877
Experience
Entry Level (0 - 2 years)
Education
Bachelors Degree

JOB DESCRIPTION

GENERAL SUMMARY/ OVERVIEW STATEMENT:



The Clinical Research Associate II (CRA II) works independently under general supervision to enroll eligible patients to clinical research studies 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





SKILLS/ABILITIES/COMPETENCIES REQUIRED:

* Careful attention to details

* Good organizational skills

* Ability to follow directions

* Good communication skills

* Computer literacy

* Working knowledge of clinical research protocols

* Ability to demonstrate respect and professionalism for subjects rights and individual needs

The Clinical Research Coordinator II should also possess:

*

Ability to work independently and as a team player * Analytical skills and ability to resolve technical problems

* Ability to interpret acceptability of data results

* Working knowledge of data management program





EDUCATION:

* Bachelors 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.

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.