Clinical Research Coordinator I - Res TR - Cardiology

  • Boston, MA, USA
  • Full-time
  • Employment Type: Full Time
  • Shift: Days
  • Work Address: 15 Kneeland Street, Boston, MA 02111
  • Job Category (for posting purposes): Research

Company Description

It takes a lot of very smart, hard-working and talented people to provide the level of care that we give to our patients. Tufts Medical Center is an internationally respected academic medical center and we pride ourselves not only on the sophistication of the care we deliver, but the compassionate way in which we provide it. And that starts with our employees.

Job Description

This position will support our Cardiology department.

The Clinical Research Coordinator is responsible for managing and assisting the Cardiogenic Shock Working Group Principal Investigator and research team in the coordination of all activities of the working group as required for successful implementation of the study protocol(s). The Cardiogenic Shock Working Group in the CVCRI at Tufts Medical Center is the largest registry of acute mechanical circulatory support (AMCS) used in the treatment of cardiogenic shock in the United States.  Its mission includes providing insight into contemporary cardiogenic shock management; defining phenotypes of cardiogenic shock; and identifying new targets of therapy and informing novel device development for left, right and biventricular support. 

General Duties:

  • Perform study start-up and continuing review activities – prepares regulatory documents and submission to the IRB (local and WIRB).  Participate with PI in writing or revising of protocols, DSMB, Manual of Operations.  Assist with application for IND.  Submit documents to FDA as needed.
  • Coordinate and attend sponsor prequalification visits, monitor visits and study termination visits. 
  • Follow study and site-specific procedures including the plan for screening, recruitment, enrollment including informed consent, subject visit management, and follow-up.
  • Perform data entry, maintain source documents, computer databases, subject screening logs and protocol deviation logs.  Ensure accuracy and integrity of study data. Respond to data clarification requests in a timely manner.  
  • Work with study staff to monitor activities and perform quality assurance and quality control checks to make sure all requirements are met and that the protocol and all study-specific procedures are being followed correctly including, but not limited to:
    • Protocol compliance
    • Informed consent
    • Data collection and source documentation
    • Data queries resolution
    • Timely submission of CRF’s to Data Management Center
    • Interact with Investigational Pharmacy for drug accountability and control
    • Subject sample collection and chain of custody, specimen processing and shipping
    • Safety reporting

Qualifications

  • Bachelor's degree required.

JOB KNOWLEDGE AND SKILLS:

  • Familiarity with, or willingness to learn, the Code of Federal Regulations pertaining to clinical research, and ICH GCP Guidelines.
  • Clinical research experience preferred.
  • Excellent organizational and time management skills; ability to prioritize quickly and appropriately
  • Strong interpersonal skills including verbal skills, flexibility.
  • Knowledge of Microsoft Office Databases (Word, EXCEL, ACCESS)
  • Phlebotomy skills preferred, but will train.
  • IATA training preferred, but will train.

An equivalent combination of education and experience, which provides proficiency in the areas of responsibility listed above, may be substituted for the above education and experience requirements.

 

WORKING CONDITIONS/PHYSICAL DEMANDS:

  • Consistent with a clinical and office environment.
  • Exposure to patients, blood pathogens, and urine, skin, and tissue samples.

Additional Information

AMERICANS WITH DISABILITIES STATEMENT:

Must be able to perform all essential functions of this position with reasonable accommodation if disabled.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

All your information will be kept confidential according to EEO guidelines.

AMERICANS WITH DISABILITIES STATEMENT:

Must be able to perform all essential functions of this position with reasonable accommodation if disabled.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

All your information will be kept confidential according to EEO guidelines.

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