Clinical Research Coord. I
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POST DATE 9/2/2016
END DATE 12/13/2016
Massachusetts General Hospital(MGH)
JOB DESCRIPTIONGENERAL SUMMARY/ OVERVIEW STATEMENT:
The Cystic Fibrosis Clinical Research Center at Massachusetts General Hospital seeks a Clinical Research Coordinator I. Under the general supervision of the Cystic Fibrosis Center Director, the CRC I will assist with research study subjects, staff, sponsors, and third-party vendors to run clinical research studies. The CRC I also works professionally with clinic staff and internal hospital departments to ensure that hospital and clinic protocols are followed. The CRC I consistently strives to assure and improve the quality of all aspects of the Cystic Fibrosis Clinical Research program.
Cystic fibrosis (CF) is an inherited disorder affecting approximately 30,000 people in the United States. While classified as a rare disease, CF is one of the most common life-limiting inherited diseases in the US. The MGH CF Clinical Research Center is comprised of 2 pulmonologists who treat adult cystic fibrosis patients, 3 pediatric pulmonologists, 2 research staff, and a research manager. Our mission is to develop new therapies, improve current treatments, and explore new questions about CF pathophysiology. The research team is responsible for between 10 and 20 clinical trials including observational patient registry studies, investigator-initiated quality improvement studies, and interventional drug trials. Of the 250 CF patients seen at MGH, the research team works primarily with adults and adolescents, engaging patients and their families in research. The past 20 years have seen life expectancies for cystic fibrosis patients increase into their forties due to advances in care.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
* Completes required hospital, departmental, disease-specific, and study-specific training.
* Works directly with subjects to execute assigned studies by:
* Meeting or speaking with patients to assist in recruitment for clinical trials,
* Providing basic explanations of studies to patients and families,
* Scheduling study visits and reminding participants of their upcoming visits,
* Assists with interviewing study participants to collect accurate study data
* Administering and scoring questionnaires
* Performing and documenting study procedures such as vital signs collection, EKG, and spirometry, and presenting these to the PI group for review
* Assist with collecting, processing, and shipping blood, urine, sweat, sputum, and stool samples
* May obtain informed consent from subjects for some simple studies, in accordance with hospital policy.
* Assists with study regulatory submissions and maintenance by:
* Providing regulatory documents to the sponsor
* Assisting in budget reviews
* Assist with composing and amending consent forms, protocol summaries, and other documents for sponsor and/or IRB review
* Assisting in the completion of Insight e-IRB applications
* Ensuring that study documents are stored, maintained, and routed in compliance with applicable federal, hospital, departmental, and study-specific regulations.
* Maintaining study records including logs
* Assists with Quality Assurance/Quality Control and auditing/monitoring procedures by:
* Scheduling sponsor/third party monitoring visits
* Assisting the monitor in his/her data and protocol reviews, and appointments
* Self- and peer-reviews documented procedures
* Working with the Research Assistant to resolve data queries and ensure that data in electronic databases are accurate
* Works directly with the PI group to execute assigned studies by:
* Reviewing patient medical records to assist with identifying study candidates
* Assists with preparing safety reports and other study progress reports for PI review
* Ensuring that PI group receives results of study tests and procedures
* Represents CF Research at weekly Cystic Fibrosis team meetings, annual TDN meetings, investigator meetings, and additional training seminars as required.
* Takes initiative when working independently and as an easily-engaged team member.
* Good verbal & written communication skills and organization skills.
* Ability to demonstrate respect for and professionalism toward subjects, their rights and individual needs.
* Preliminary knowledge of clinical research policy.
* Computer literacy, including Office Outlook, Excel, and Word.
LICENSES, CERTIFICATIONS: None.
EDUCATION: BS/BA required, biology degree preferred.
Typically new graduate with relevant course or project work. Previous clinical research preferred, but lab research experience or no experience acceptable.
SUPERVISORY RESPONSIBILITY: May assist in orienting and training new research assistants (1.0 FTE).
FISCAL RESPONSIBILITY :
Assists in the creation of study budgets and performs billing and invoicing for assigned studies, approximately $100,000 per annum.
This is not a laboratory position. Most of the CRCs time will be spent in the clinical research office, which adjoins one of the two outpatient clinics at which study participants are seen. Some time may be spent at the other outpatient clinic, which is nearby. Meetings with physicians and patients will require trips to other buildings on the main hospital campus.
Some overnight travel approximately 10 days per year is required.
Work entails approximately 20% walking/standing, and some light lifting. Most days start around 8:00 or 8:30, but occasionally begin earlier to accommodate subjects who wish to come in before going to work.
Research manager regularly reviews progress of work.
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.