- Assist with documentation for clinical device development and fabrication
- Assist with documentation for clinical study submissions
- Assist with regulatory documentation
- Assist with screening and recruitment of research study participants
- Assist with clinical research study procedures
- Assist with writing protocols and manuscripts
- Assist with maintaining records and databases
- Verify accuracy of study forms and updates study forms per protocol
- Assist with formal audits of data documents, patient visits and procedures
- Assist with regulatory binders and QA/QC procedures.
- Prepare data for analysis and data entry
- 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
- 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.
- Careful attention to details
- Good organizational skills
- Good communication skills
- Ability to follow directions
- Ability to work independently and as a team member
- Computer literacy
- Basic knowledge of clinical research protocols
- Ability to demonstrate respect and professionalism for research participants' rights and individual needs
- Analytical skills and ability to resolve technical problems
- Ability to interpret acceptability of data results
- Working knowledge of data management program
- 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.
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Clinical Research Coordinator - Boston, United States - Partners Healthcare System
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Description
GENERAL SUMMARY STATEMENT:
A Clinical Research Coordinator position is available in the Tearney Laboratory at the Wellman Center for Photomedicine at Massachusetts General Hospital.
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:
EDUCATION:
BA/BS Required
EXPERIENCE:
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
The Clinical Research Coordinator II should also possess:
SUPERVISORY RESPONSIBILITY:
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, e.g., blood-borne pathogens, hazardous electrical, e.g., high voltage, or mechanical energy.