What are the responsibilities and job description for the CLINICAL RESEARCH ASSISTANT II RENAL DIVISION position at Brigham and Women's Hospital?
OVERVIEW:
The Clinical Research Assistant is responsible for management of all human research samples and data collected for research projects in the Weins Lab. It includes IRB management and compliance enforcement, biosample procurement, consenting, creation and management of a biorepository, creation and management of confidential clinical data and limited fiscal responsibility of human subjects management related budget. His/her contributions are vital for the compliance of our research projects with IRB guidelines, and form the foundation of our translational scientific studies on the mechanisms of proteinuric kidney diseases and biomarker studies. He/she is highly competent and experienced in IRB management, Freezerworks and RedCap software. He/she does not receive pendent resources, however, their contribution is essential to the success and compliance of our human research studies.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- creates and independently manages complex human subjects research protocols via the BWH IRB, executes compliance with human research guidelines (in collaboration with and supervised by Dr. Weins) including obtaining patient consent, ensuring CITI certification of all investigators, and manages IRB protocols including all staff and study amendments and renewals
- creates and manages a sample biorepository of already collected and to be collected biological samples from patients under the approved IRB protocols using Freezerworks
- consents patients in in- and outpatient settings throughout MGB hospitals and clinics
- attends procedures to collect biological samples from inpatients and outpatients after consenting of patients according to outlined standard operating procedures
- aliquots, processes and adequately stores biosamples
- oversees biosample transfer/shipping to and from collaborators as outlined in IRB protocols
- collects and manages of confidential clinical patient data in accordance with HIPAA guidelines and IRB protocols using RedCap
- manages and restricts access to Freezerworks and RedCap databases
- reports directly to Dr. Weins and exercises judgement in promptly communicating non-compliance
- attends weekly individual meetings with Dr. Weins and biweekly lab meetings
- assists with grant writing and manuscript preparation as it pertains to the human research subjects sections
- Performs ordering and limited laboratory management duties as it pertains to human subjects research
- can be trained in ELISA, Co-IP, Western Blot, immunohistochemical techniques and perform these if desired
- is given the opportunity to attend research and clinical conferences
- will receive mentoring and career counseling
BASIC QUALIFICATIONS
Minimum bachelor's degree, advanced degree (Masters Degree in Biological Sciences or related field) is preferred, appropriate to the field of research and with demonstrated evidence of competency with highly specialized and developed skills, publications and/or experience.
Minimum one year of related experience.
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
Skilled with demonstrated knowledge of human subjects research compliance and procedures (particularly in IRB management, Freezerworks and RedCap)
Able to exercise independent judgment and leadership
Experience in biosample handling and processing
Experience in laboratory management
Familiarity with management/maintenance of Biosafety protocols
Training in Human Subjects Research and familiarity with ethical standards
Aptitude for independent analytical thinking
Ability to responsibly manage a research budget
Strong writing skills
Excellent organizational skills and interest in managing a biological sample inventory (using FreezerWorks, RedCAP, etc)
Experience in basic statistical methods and good math skills (in particular EXCEL, GraphPad Prism)
The Brigham and Women's Hospital, Inc. is an Equal Opportunity 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. Brigham and Women’s Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.
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