Clinical Research Coordinator at Massachusetts General Hospital(MGH) in Boston, Massachusetts

Job Description:

GENERAL SUMMARY/ OVERVIEW STATEMENT:


Under the general direction of the Clinical Research Program Manager, the Clinical Research Coordinator I/II assists with the screening, recruitment of study patients, and implementation of study procedures. The Coordinator may also obtain informed consent once study patients have been identified and educated about the study. Management of patients occurs under general physician supervision. The clinical research coordinator is responsible for reviewing lab results to ensure that protocol requirements are met and that abnormalities are reported to the Research Nurse. Patient data is collected from numerous sources including Clinical Chemistry Lab, Radiology, and other patient records related to specific protocols and put in research databases and patient charts (lab results, etc.).


Collaborates with supervisor to create and maintain a database of clinical protocol data. The Coordinator will be a resource for teaching other personnel about such databases. Carries out a wide range of moderate to complex data management functions with a full understanding of the principles underlying the choice and use of statistical tests; responsible for creation of graphics/slides for manuscripts and oral presentations. Collaborates with supervisor in writing and editing material for publication.



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 records and databases


• Uses software programs to generate graphs and reports


• Assists with recruiting patients for clinical trials


• Obtains patient study data from medical records, physicians, etc.


• Conducts library 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


• Writes consent forms


• Verifies subject inclusion/exclusion criteria


• Performs administrative support duties as required

A Clinical Research Coordinator II performs the duties of a Clinical Research Coordinator I (above) and may also:

• 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 evaluation 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

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

• Careful attention to details


• Good organizational skills


• Ability to follow directions


• Good communication skills


• Computer literacy


• Working knowledge of clinical research protocols


• Ability to demonstrate respect and professionalism for subjects' rights and individual needs

The Clinical Research Coordinator II should also possess:

• Ability to work independently and as a team player


• Analytical skills and ability to resolve technical problems


• Ability to interpret acceptability of data results


• Working knowledge of data management program

Qualifications

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.


• Those with a minimum of 1-2 years of directly related work experience will be considered for a Clinical Research Coordinator II position.

SUPERVISORY RESPONSIBILITY (if applicable):

• 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.

EEO Statement

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. Apply Now