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:

1. 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.

2. Verifies accuracy of study forms

3. Updates study forms per protocol

4. Documents patient visits and procedures

5. Maintains research data, patient files, and study database

6. Acts as liaison between Sponsor and PI

7. Collects, organizes and manages study and patient data

8. Develops and implements recruitment strategies

9. Screens patients for enrollment into clinical trials and following research subjects per study protocol.

10. Verifies subject inclusion/exclusion criteria

11. Acts as study resource for patient and family

12. Submits all Institutional Review Board (IRB) documentation

13. Prepares documents and study binders for FDA audits (if needed)

14. Orients and trains junior team members on the study protocols as appropriate

15. Prepares invoices and directs, verifies, corrects patient care charges as appropriate

16. Uses software programs to generate graphs and reports

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

18. Conducts library searches

19. Assists with regulatory binders and QA/QC procedures

20. Assists with interviewing study subjects

21. Administers and scores questionnaires

22. Provides basic explanation of study and in some cases obtains informed consent from subjects

23. Performs study procedures, which may include phlebotomy.

24. Assists with study regulatory submissions

25. Writes consent forms and obtains consent for applicable trials

26. Performs administrative support duties as required

27. Requests medical records from external institutions

28. 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.

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.