Clinical Research Coordinator

3 weeks ago


Boston, United States Partners Healthcare System Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The mission of our laboratory is to improve the quality of life for patients with celiac disease and other gluten-related disorders. The successful candidate will serve as a Clinical Research Coordinator in our center and gain interdisciplinary research experience through assisting with the conduct and management of various clinical studies pertaining to celiac disease, gluten-related disorders, and disorders associated with increased intestinal permeability. The candidate will work on both clinical and translational research projects that recruit both adult and pediatric populations. The candidate will assist with our celiac disease pediatric biorepository, industry-funded clinical trials, as well as other longitudinal studies ongoing at our center.

Projects involve screening/recruiting and enrolling subjects, scheduling patient visits, as well as attending in-person visits at either clinic or in the endoscopy unit. The candidate will coordinate and monitor the collection of study-specific clinical data and specimens (blood, urine, stool, tissue samples, etc.). Major responsibilities also include management of IRB documentation of the approved research project, maintain regulatory files, review of data collection and entry, conduct of study follow-up visits, and data storage and management.

The candidate will be overseen by the Principal Investigator, Project Manager, as well as other Clinical Research Coordinator II/Senior Clinical Research Coordinators in the center.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

In addition to the duties of a Clinical Research Coordinator;

* Conducts basic laboratory tasks including sample aliquoting, organization, and storage
* Updates study forms per protocol
* Prepares/organizes data for analysis
* Monitors electronic data collection procedures including checking data for timely collection (according to the study schedule) and completeness
* Assists with formal audits of data
* Documents patient visits and procedures
* Prepares materials for patient visits including stool, urine, saliva, and blood sample collection kits
* Conducts research-specific visits with subjects
* Assists with regulatory binders and QA/QC procedures
* Provides basic explanation of study and obtains informed consent from subjects
* Assists with study regulatory (IRB) submissions
* Assists external study sites with study management according to the Manual of Operations and Standard Operating Procedures

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

* Careful attention to detail
* Excellent organizational and leadership skills
* Ability to complete work independently, multi-tasking and balancing deadlines when appropriate
* Ability to make independent and effective decisions
* Excellent written and oral communication skills with both colleagues and patients, including comfort with speaking on the phone
* Computer literacy, including basic word processing and conduct of scientific literature reviews
* Working knowledge of clinical research protocols and their associated regulatory requirements
* Ability to demonstrate respect and professionalism for subject's rights and individuals needs

EDUCATION:

BA/BS in a scientific area of study is required. A pre-medical or health-related concentration and relevant coursework (biology, chemistry, immunology, epidemiology, etc.) is preferred.

EXPERIENCE:

Previous research experience including interface with research subjects, collection of clinical data, and/or familiarity with IRB requirements and regulatory documentation of research is preferred. Previous laboratory experience including knowledge of basic laboratory techniques and materials is also preferred.

WORKING CONDITIONS:

The candidate will work in an office space (connected to the associated laboratory) in the Jackson building on the main campus of Mass General Hospital. The floor is occupied by members of the Mucosal Immunology and Biology Research Center and is conducive to collaborative work. There are no heavy lifting or carrying requirements.



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