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Clinical Research Coordinator

1 month ago

Boston, United States Mass General Brigham Full time
Clinical Research Coordinator-(3299019)

Description

Clinical Research Coordinator

A part-time ClinicalResearchCoordinatorpositionisavailableintheTearneyLaboratoryattheWellmanCenterforPhotomedicine at Massachusetts General Hospital. The Clinical Research Coordinator will work 24 to 30 hours per week under the general guidance of the Clinical/Regulatory Teamsupervisor.

The Tearney Laboratory () is a multidisciplinary research laboratory that invents, designs, and validates innovative optical diagnostic imaging devices in human patients. One focus of the laboratory is the development and clinical translation of imaging devices that conduct microscopy of entire organ systems in patients in vivo.

A key element of the lab’s research involves a clinical/regulatory team to facilitate translation of these medical devices. A critical member of the clinical/regulatory team is a clinical research coordinator who is dedicated to regulatory compliance.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The Clinical Research Coordinator position will consist of but may not be limited to the following responsibilities:

·Assist with documentation for clinical device development andfabrication

·Assist with documentation for clinical studysubmissions

·Assist with regulatorydocumentation

·Assist with screening and recruitment of research studyparticipants

·Assist with clinical research study procedures

·Assist with writing protocols andmanuscripts

·Assist with maintaining records anddatabases

·Verify accuracy of study forms and updates study forms perprotocol

·Assist with formal audits of data documents, patient visits andprocedures

·Assist with regulatory binders and QA/QCprocedures.

·Prepare data for analysis and dataentry

A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:

·Maintain research data, patient fields, regulatory binders and study databases

·Perform data analysis and QA/QC data checks

·Organize and interpret data

·Develop and implement recruitment strategies

·Act as a study resource for patient and family

·Monitor and evaluate lab and procedure data

·Evaluate study questionnaires

·Contribute to protocol recommendations

·Assist with preparation of annual review

·May assist PI to prepare complete study reports

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

·Careful attention todetails

·Good organizationalskills

·Good communicationskills

·Ability to followdirections

·Ability to work independently and as a teammember

·Computerliteracy

·Basic knowledge of clinical researchprotocols

·Ability to demonstrate respect and professionalism for research participants' rights and individualneeds

The Clinical Research Coordinator II should also possess:

·Analytical skills and ability to resolve technical problems

·Ability to interpret acceptability of data results

·Working knowledge of data management program

SUPERVISORY RESPONSIBILITY:

·A Clinical Research Coordinator I does not have any supervisory responsibility.

·A Clinical Research Coordinator II may assist with the training and orientation of new staff members.

WORKING CONDITIONS:

Clinical, office, and laboratory settings. 

Work may be performed at multiple sites within Massachusetts. Must be flexible in working in multiple locations.

May work in research laboratory or clinical site with potential exposure to biological agents, ., blood-borne pathogens, hazardous electrical, ., high voltage, or mechanical energy. Occasional lifting of heavy objects, typically not exceeding 75 pounds/person may be requested. MGH policies governing appropriate laboratory attire will be followed including use of personal protective equipment.

Qualifications

EDUCATION: 

BA/BS Required. 

EXPERIENCE:

·Relevant course work or project work preferred.

·Familiarity with regulatory environment strongly preferred

·Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research II position.