Job Description

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Multi-Center Clinical Research Associate/Monitor works with minimal supervision to assist with the activation, regulatory coordination and data quality monitoring of a portfolio of Investigator-initiated, multi-center clinical trials within the MGH Cancer Center This role focuses on centralized trial coordination and does not include direct patient contact.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Principal responsibilities include, but are not limited to:

* Tracks and monitors the progress of the trial across all participating sites (i.e. accrual, biospecimen collection and transfer, reportable events, regulatory submissions)

* Verifies patient eligibility via source document review and analysis of clincial data; registers patients from external site to the trial
* Maintains Trial Master File and Site-Specific Files
* Conducts interim monitoring visits (Domestic travel required for onsite monitoring <50%)
* Monitors and evaluates ongoing protocol and data compliance at participating sites, issues queries and completes corresponding monitoring reports
* Performs source document verification and drug accountability
* Reviews study site regulatory binder and essential documents for completeness and accuracy
* Corresponds with participating sites and supports all trial activities
* Answers questions about eligibility, study procedures or data entry
* Develops and distributes multi-center meeting agendas and minutes
* Provides routine updates
* Updates the Sponsor-Investigator with study metrics as requested.

SKILLS AND COMPETENCIES:

* Careful attention to details

* Good organizational skills
* Ability to follow directions
* Excellent written and verbal 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 identify and resolve problems
* Ability to interpret acceptability of data results
* Working knowledge of data management program

EDUCATION:

* Bachelors degree required.

EXPERIENCE:

* New graduates with some relevant course/project work or those without any prior research experience will be considered for the Clinical Research Associate I position outlined above.
* Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Associate II position.

SUPERVISORY RESPONSIBILITY (if applicable):

* A Clinical Research Associate I does not have any supervisory responsibility.
* A Clinical Research Associate II may assist with the training and orientation of new staff members.

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