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Responsibilities

GENERAL SUMMARY:

The Clinical Research Associate is responsible for all administrative and operational aspects of clinical research within the Thoracic Surgery Division. He/she monitors patient accrual to surgical trials at the Brigham and Women's Hospital (BWH) and Dana-Farber Cancer Institute (DFCI), including actively recruiting patients on trial, following patients through the protocol treatment program and follow-up, and completing data forms and data management required by the studies.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Responsible for collecting data and maintaining patient information database for studies.

2. Responsible for IRB and other regulatory submissions for protocol submissions and updates, renewals, adverse event reports, deviations, data audits, etc.

3. May be required to do data analysis and run various reports.

4. Interacts with patients/subjects with regard to consenting, data collection, follow-up, and other tasks as assigned. May serves as a liaison between patient and physician.

5. Performs quality control procedures to ensure integrity of data in clinical research database, as determined by Clinical Research Manager.

6. As required, collects biologic samples and specimens and ensures protocol adherence in the operating room, laboratory, and intensive care settings per study guidelines.

7. Answers any phone calls and inquiries regarding clinical research database or study protocol. Refers participants when appropriate to supervisor or clinical staff.

9. All other duties, as assigned.

Requirements

QUALIFICATIONS:

In order to be eligible for an interview the following skills are necessary: previous clinical work including consenting patients AND basic data management.

Master's Degree preferred.

SKILLS/ABILITIES/COMPETENCIES REQUIRED:

1. Experience using Microsoft Excel, Access and Word are required.

2. Experience using Electronic Medical Records for data collection and review is preferred.

3. Knowledge of statistical software required and experience with SAS and or SQL is preferred.

4. Knowledge of clinical research protocols and clinical trials process, with at least 2 years clinical research experience is preferred.

5. Knowledge of medical terminology.

6. Ability to demonstrate professionalism and respect for subjects rights and individual needs.

7. Excellent interpersonal skills are required for working with the study participants.

8. Careful attention to detail.

9. Good oral and written communication skills.

SUPERVISORY RESPONSIBILITIES:

None

WORKING CONDITIONS:

Data office, operating room, and laboratory working conditions include working under pressure to meet deadlines and meetings, moderate stress.

DRESS CODE:

Professional dress code required.

Shift

Day Shift

EEO Statement

An EEO, AA, VEVRAA Employer