Clinical Research Associate II
Clinical Research Associate II
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Job Description
EDUCATION:
- BA/BS degree required
EXPERIENCE:
- Minimum of 12 years of related experience or completion of the CCPO New Staff Orientation program including completion of competency assessment
GENERALSUMMARY/ OVERVIEW STATEMENT:
As a direct report to the GU Clinical Research ProjectManager the Clinical Research Associate II (CRA II) works independently toenroll eligible patients to clinical trials and manage all aspects of datacollection and submission for multiple cancer trials. Prior experienceand comfort with medical terminology is preferred. Prior clinicalresearch coordination/data management experience preferred.
PRINCIPALDUTIES AND RESPONSIBILITIES:
The following duties will beperformed independently:
- Verifies patienteligibility via chart abstraction and clinical analysis of case data
- Collects and interpretsdata necessary for enrollment registers patients
- Monitors andevaluates protocol compliance
- Manages datacollection via chart abstraction and submits data in a timely fashion
- Maintainsresearch charts for all assigned trials and enrolled patients
- Monitors andreports adverse events as required by institutional/federal regulations
- Coordinates andprocesses tissue samples as required by protocol
- Preparessubmission of protocol revisions and safety reports to the IRB
- Prepares annualprogress reports for IRB renewal of ongoing studies
- Organizes andattends onand offsite Investigator meetings
- Organizesmonitoring visits as requested by sponsors and makes data corrections asrequired by monitor
SKILLS/ABILITIES/COMPETENCIESREQUIRED:
- High degree ofcomputer literacy
- Ability to workindependently and as a team member
- Analytical skillsand ability to resolve problems
- Ability tointerpret acceptability of data results
- Working knowledgeof data management programs
SUPERVISORYRESPONSIBILITY (if applicable):
- May assist withorientation and training of new staff
WORKINGCONDITIONS:
- Duties will beperformed in an office setting.
Massachusetts General Hospital is an Equal Opportunity Employer. By embracing diverse skills perspectives and ideas we choose to lead. Applications fromprotected veterans and individuals with disabilities are strongly encouraged.
Required Experience:
IC
Employment Type
Full-Time
