Clinical Research Coordinator

About the job

General Summary/ Overview Statement

The Massachusetts General Hospital Division of Cardiology is seeking a highly motivated and experienced individual for a Clinical Research Coordinator (CRC) I position to assist with ongoing and future clinical research studies.

The CRC I must be able to multi-task in a dynamic clinical research setting. The ability to work well in a team is a must. This is the ideal position for someone looking to work with a dedicated group of people to make new and enhanced medical device technology available to patients with an array of cardiac conditions. The CRC I will gain invaluable experience in the field of Cardiology in an academic clinical research setting.

This is a full-time (40 hours/week) position; evening and weekend hours may occasionally be required to facilitate the conduct of the study.

This position is ideal for someone interested in pursuing graduate studies or a career in the fields of medicine, public health, or clinical research. It involves extensive patient interaction as a member of a clinical research team.

Principal Duties And Responsibilities

The Clinical Research Coordinator I has the following duties and responsibilities:

• Manages investigational device trials under the supervision of the PI, including data entry and accuracy, Institutional Review Board maintenance, and extensive patient interaction with study participants.
• Verifies accuracy of study forms
• Updates study forms per protocol
• Documents patient visits and procedures
• Maintains research data, patient files, and study database
• Acts as liaison between Sponsor and PI
• Collects, organizes and manages study and patient data
• Develops and implements recruitment strategies
• Screens patients for enrollment into clinical trials and following research subjects per study protocol.
• Verifies subject inclusion/exclusion criteria
• Acts as study resource for patient and family
• Submits all Institutional Review Board (IRB) documentation
• Prepares documents and study binders for FDA audits (if needed)
• Orients and trains junior team members on the study protocols as appropriate
• Prepares invoices and directs, verifies, corrects patient care charges as appropriate
• Uses software programs to generate graphs and reports
• Obtains patient study data from medical records, physicians, etc.
• Conducts library searches
• 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 and obtains consent for applicable trials
• Performs administrative support duties as required
• Requests medical records from external institutions
• Maintains a good understanding of the study protocols and study start-up process
  
  

Fiscal Responsibity

May monitor and manage study funds. Responsible for preparing invoices and for directing, verifying, and correcting patient care charges as appropriate.

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
  
  

Licenses, Certifications

Training in CITI and GCP preferred.

Education

• Bachelor’s degree required.
  
  

Experience

Previous experience in clinical research is a plus.

Primary Location

MA-Boston-MGH Main Campus

Work Locations

MGH Main Campus

Job

Clinical

Organization

Massachusetts General Hospital(MGH)

Schedule

Full-time

Standard Hours

40

Shift

Day Job

Employee Status

Regular

Recruiting Department

MGH Cardiovascular Research Center