Clinical Research Coordinator

Boston, MA, United States

Job Description - Clinical Research Coordinator (3289695)

Clinical Research Coordinator - ( 3289695 )

GENERAL SUMMARY STATEMENT:

A Clinical Research Coordinator position is available in the Tearney Laboratory at the Wellman Center for Photomedicine at Massachusetts General Hospital. The Clinical Research Coordinator will work under the general guidance of the Clinical/Regulatory Team supervisor.

The Tearney Laboratory (www.tearneylab.org) is a multidisciplinary research laboratory that invents, designs, and validates innovative optical diagnostic imaging devices in human patients. One focus of the laboratory is the development and clinical translation of imaging devices that conduct microscopy of entire organ systems in patients in vivo.

A key element of the lab’s research involves a clinical/regulatory team to facilitate translation of these medical devices. A critical member of the clinical/regulatory team is a clinical research coordinator who is dedicated to regulatory compliance.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The Clinical Research Coordinator position will consist of but may not be limited to the following responsibilities:

· Assist with documentation for clinical device development and fabrication

· Assist with documentation for clinical study submissions

· Assist with regulatory documentation

· Assist with screening and recruitment of research study participants

· Assist with clinical research study procedures

· Assist with writing protocols and manuscripts

· Assist with maintaining records and databases

· Verify accuracy of study forms and updates study forms per protocol

· Assist with formal audits of data documents, patient visits and procedures

· Assist with regulatory binders and QA/QC procedures.

· Prepare data for analysis and data entry

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 evaluate lab and procedure data

· Contribute to protocol recommendations

· Assist with preparation of annual review

· May assist PI to prepare complete study reports

EDUCATION:

BA/BS Required

EXPERIENCE:

· Relevant course work or project work preferred.

· Familiarity with regulatory environment strongly preferred

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

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

· Careful attention to details

· Good organizational skills

· Ability to follow directions

· Ability to work independently and as a team member

· Computer literacy

· Basic knowledge of clinical research protocols

· Ability to demonstrate respect and professionalism for research participants' rights and individual needs

The Clinical Research Coordinator II should also possess:

· Analytical skills and ability to resolve technical problems

· Ability to interpret acceptability of data results

· Working knowledge of data management program

SUPERVISORY RESPONSIBILITY:

· 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.

WORKING CONDITIONS:

Clinical, office, and laboratory settings.

Work may be performed at multiple sites within Massachusetts. Must be flexible in working in multiple locations.

May work in research laboratory or clinical site with potential exposure to biological agents, e.g., blood-borne pathogens, hazardous electrical, e.g., high voltage, or mechanical energy. Occasional lifting of heavy objects, typically not exceeding 75 pounds/person may be requested. MGH policies governing appropriate laboratory attire will be followed including use of personal protective equipment.

EDUCATION:

BA/BS Required

EXPERIENCE:

· Relevant course work or project work preferred.

· Familiarity with regulatory environment strongly preferred

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

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

· Careful attention to details

· Good organizational skills

· Good communication skills

· Ability to follow directions

· Ability to work independently and as a team member

· Computer literacy

· Basic knowledge of clinical research protocols

· Ability to demonstrate respect and professionalism for research participants' rights and individual needs

The Clinical Research Coordinator II should also possess:

· Analytical skills and ability to resolve technical problems

· Ability to interpret acceptability of data results

· Working knowledge of data management program

SUPERVISORY RESPONSIBILITY:

· 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.

WORKING CONDITIONS:

Clinical, office, and laboratory settings.

Work may be performed at multiple sites within Massachusetts. Must be flexible in working in multiple locations.

May work in research laboratory or clinical site with potential exposure to biological agents, e.g., blood-borne pathogens, hazardous electrical, e.g., high voltage, or mechanical energy. Occasional lifting of heavy objects, typically not exceeding 75 pounds/person may be requested. MGH policies governing appropriate laboratory attire will be followed including use of personal protective equipment.

Massachusetts General Hospital is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Primary Location Work Locations MGH Main Campus

Job Job Clinical

Organization Organization Massachusetts General Hospital(MGH)

Schedule Schedule Full-time

Standard Hours 40

Shift Shift Day Job

Employee Status Employee Status Regular

Recruiting Department MGH Wellman Center for Photomedicine

#J-18808-Ljbffr