*We do not consider incomplete or Quick Apply applications. *
About the Organization:
BIOMEDICAL RESEARCH ALLIANCE OF NEW YORK LLC (‘BRANY’)
BRANY is the premiere resource for research support services for hospitals, universities, government agencies, and academic medical centers, as well as biotechnology, pharmaceutical and device companies. The services offered by BRANY, which are designed to improve research efficiency and quality, include but are not limited to ethics review, budget and contract negotiation, auditing, monitoring, and research billing and collections. BRANY was founded in 1998 and is owned by four leading academic medical centers — NYU School of Medicine, Montefiore Medical Center, Icahn School of Medicine at Mount Sinai, and Northwell Health.
Other divisions of BRANY include HRP Consulting Group (HRP) that provides human research protection consulting services, Tech Software, a leading provider of SaaS compliance solutions, and the CITI Program, a trusted provider of online research, ethics and compliance training. The CITI Program serves millions of learners in the U.S. and around the world.
BRANY is a growing company with a unique company culture that deeply cares about its team members. We are seeking hardworking, collaborative, ambitious, and accountable professionals looking to grow in an industry that contributes to the advancement of science, fosters learning, and facilitates innovation that promotes health and improves quality of life.
General Summary:
The Junior Associate IRB Coordinator is responsible for assisting with processing submissions for the IRB and IBC department. Responsibilities include follow-up and processing of new applications and modification/continuing review requests. This includes distinguishing between expedited and full board reviews using knowledge of IRB/IBC regulations and policy, acting as liaison between the research community and IRB/IBC members, providing written notices of IRB/IBC determinations, modifying consent documents when applicable, and maintaining accurate records in IRBManager and SMART.
Duties/Responsibilities:
Assists with preparation of IRB/IBC submissions, which become part of the meeting agendas or are prepared for expedited review. Submission handling must be completed with accuracy prior to distribution to committee members.
Assists with other IRB/IBC meeting agenda preparation or administrative tasks as needed.
As needed, attends IRB/IBC meetings and assists with written communication of decisions and generating meeting minutes in a timely fashion.
Prepares submissions for IRB/IBC agenda and assigned reviewer(s).
Assists with providing investigators with notices of the committee’s decisions, and editing consent forms as required subsequent to review.
Assists with ensuring updates are provided to internal and external contacts regarding the outcome of the committee’s review within one business day of the meeting.
Maintains and updates information in BRANY computer databases (IRB Manager, SMART), as applicable.
Trains and develops new or inexperienced staff in the IRB/IBC Department or BRANY staff.
Assists Director of the IRB or Department staff in other activities as needed.
Uses communication skills to establish and maintain good working relationships with IRB members, doctors, site liaisons, investigators, CRO representatives, and sponsors.
Uses writing skills to effectively communicate via email and written correspondence.
Works independently, takes initiative and troubleshoots daily routine problems as they occur. Develop or recommend a plan of corrective action for complex non-routine issues.
Works as a team member on special, nonrecurring and ongoing projects.
14. Works as a team member on special nonrecurring and ongoing projects. (*)
Non-Essential Functions will be noted by asterisk (*).
Education required:
Bachelor’s Degree or equivalent life experience. Science or Health related degree preferred.
Experience Required:
2+ years’ experience working for an institutional review board or related research field.
Qualifications:
Familiarity with human subject research, FDA and/or OHRP regulations, IRB/IBC committee administration, GCP practices a plus. Microsoft Office at the intermediate level or above. Strong writing and communication skills.
SPONSORSHIP IS NOT AVAILABLE
Location:
Remote
Physical Demands and Environment:
This position operates in an office environment using standard office equipment. It is largely a deskbound role. The position requires the individual to see, talk and hear. The employee is frequently required to use hands, fingers, and reach with hands and arms.
Travel:
Minimal or no travel is expected for this position
Salary/Exempt Status:
$50,000 – $53,000/Non-exempt
Benefits:
· Flexible schedule
· Medical, dental, and vision insurance
· Retirement benefits
· Group life Insurance
· Voluntary supplemental insurance
· Generous paid time off
EEO and Accommodations:
BRANY is committed to having a diverse population and a policy of equal opportunity for all employees, and applicants for employment, without regard to race, color, creed/religion, sex, sexual orientation, gender identity characteristics, genetic predisposition or carrier status, domestic violence victim status, marital status, national origin, age, disability, status as a veteran or special disabled veteran, or citizenship status, in accordance with applicable federal, state, and local law. BRANY also recognizes same-sex marriages and the employment rights of those in the LGBT community. BRANY is an Equal Opportunity/Affirmative Action employer.
BRANY is committed to the full inclusion of all qualified individuals. In keeping with our commitment, BRANY will take the steps to ensure that people with disabilities are provided reasonable accommodations. Accordingly, if reasonable accommodation is required to fully participate in the job application or interview process, to perform the essential functions of the position, and/or to receive all other benefits and privileges of employment, please contact a BRANY representative at HR@brany.com