Clinical Research Coordinator I, Amputation Surgery

The CRC will join the Principal Investigator, Program Manager, and other members of the research and clinical teams at Brigham and Women's Hospital to perform groundbreaking work towards improving the way amputations are performed. This role will afford opportunities to work with patients in both research and clinical settings, learn clinical trial management, observe novel amputation surgical procedures, and become familiar with Good Clinical Practice and other federal and institutional regulatory practices. The CRC will work closely with patients, Plastic Surgery clinical staff, administrative staff throughout the hospital, and many of our collaborators at other institutions under the guidance of the Program Manager and the Principal Investigator.

Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study. Candidates who are in the process of completing their bachelor's degree have a grace period of six months from their hire date (up to 1 year if starting per diem)to provide degree equivalency verification.

Essential Functions
Reviews proposals for compliance with sponsor and organizational guidelines; verify all sponsor requirements are met.
-Recruiting patients for clinical trials, conducts phone interviews.
-Verifies the accuracy of study forms and updates them per protocol.
-Prepares data for analysis and data entry.
-Documents patient visits and procedures.
-Assists with regulatory binders and QA/QC Procedures.
-Assists with interviewing study subjects.
-Assists with study regulator submissions.

Education
Bachelor's Degree Science required

Experience
Some relevant research project work + 0-1 year experience preferred

Knowledge, Skills and Abilities
- Careful attention to detail and good organizational skills.
- Ability to follow directions.
- Good interpersonal and communication skills.
- Computer literacy.
- Working knowledge of clinical research protocols.
- Ability to demonstrate respect and professionalism for subjects' rights and individual needs.

For more information on our research, please visit the AMI page on the MIT Media Lab website and see our current postings on clinicaltrials.gov - upper extremity amputation, residual limb revision, below-knee with e-OPRA, and below-knee with e-OPRA and magnetic beads.

Principal Duties And Responsibilities

The CRC has the following principal duties and responsibilities:

• Orients new and potential subjects to our clinical trials, including educating patients about our studies and managing recruitment, screening, and enrollment of research participants.
• Shepherds enrolled patients through the various study-related encounters, including coordinating study visits, imaging sessions, and functional outcomes testing sessions. This may also include assisting patients with insurance-related issues and travel arrangements.
• Administers questionnaires regarding limb function and quality of life.
• Serves as a liaison between subjects and PI/Program Manager and between subjects and other hospital administrative staff as appropriate.
• Participates in subject clinic visits and procedures related to their participation in research studies.
• Collects and maintains patient information and study data. This will include collecting operative data during surgical procedures.
• Maintains subjects' records and research study regulatory documentation.
• Performs research billing activities.
• Assists with compliance with the MGB IRB and other federal and institutional guidelines.
• All other activities involved with the daily management of clinical research protocols, as assigned.
• Coordinates study activities, transfer of information, and other necessary study related items between multiple study sites, regulatory bodies and sponsors in conjunction with the Program Manager
• Ensures proper communication between different disciplines participating in the research. Could be in the form of organizing meetings, dinners, etc.

Please submit a cover letter outlining your interest in this specific position and your future career goals along with your resume in your application. In addition to submitting an online application, please email your resume and cover letter to kclites@mgb.org.