Clinical Research Coordinator I

4 weeks ago

Boston, United States Partners Healthcare System Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT:

Dr. Amy Dickey is seeking to hire a clinical research coordinator for diverse and innovative projects related to the study of porphyria, a family of rare genetic diseases affecting the production of heme. Her studies include clinical trials, observational registry studies, and device studies related to the porphyrias. Currently, she is conducting both investigator-initiated and pharmaceutical company-initiated clinical trials for erythropoietic protoporphyria (EPP), which causes painful light sensitivity. Furthermore, she is developing and applying novel digital biomarkers to support disease monitoring and to serve as clinical trial endpoints in EPP. Moreover, she is also continuing to compile a disease registry for the porphyrias that includes clinical, biochemical, survey, and survey data, as well as patient samples. This registry will support multiple different research efforts related to the porphyrias, including the identification of modifiers of disease severity and penetrance, which could inform the development of new therapies. Dr. Amy Dickey works closely with Dr. Rebecca Karp in hematology. Together, they have a multi-disciplinary porphyria clinic within the hematology division at MGH.

The MGH Division of Pulmonary and Critical Care Medicine has an active and growing program in clinical and translational research. Our investigators study a variety of lung diseases including chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF), pulmonary hypertension, pleural effusion and acute lung injury. The individual hired for this position will receive general direction from the Senior Project Manager for Clinical Research and the Vice Chief for Research and will work as part of a team of clinical research coordinators to ensure successful study start-up, enrollment and close-out in compliance with MGH, Partners, NIH and FDA regulations and guidelines.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Please note, the functions below are representative of major duties that are typically associated with these positions. Specific responsibilities may vary based upon departmental needs. Similarly, not all duties that have been outlined will be assigned to each position.

* Collects & organizes patient data
* Maintains regulatory documents, subject binders and databases
* Assists with recruiting patients for clinical trials
* Reviews and abstracts data from medical records
* Conducts literature searches
* Verifies accuracy of study forms
* Updates study forms per protocol
* Documents patient visits and procedures
* Assists with regulatory binders and QA/QC procedures
* Assists with interviewing study subjects
* Administers and scores questionnaires
* Provides basic explanation of study and in some cases obtains informed consent from subjects
* Performs study procedures, which may include phlebotomy.
* Assists with study regulatory submissions
* Assists in writting study documents including consent forms, study reports, and SOP
* Conducts pre-screening and screening of potential subjects (inclusion/exclusion criteria )
* Performs administrative support duties as required

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

* Careful attention to details
* Good organizational skills
* Ability to follow directions
* Ability to work in a team environment
* Good communication skills
* Computer literacy
* Working knowledge of clinical research protocols
* Ability to demonstrate respect and professionalism for subjects' rights and individual needs

EDUCATION:

* Bachelor's 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 Coordinator I position outlined above.

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