Biomedical Engineer jobs in Levittown, NY

Description

*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.

Duties/Responsibilities:

1. The mission of the BRANY Institutional Review Board (IRB) is to protect the rights and ensure the welfare of all human research subjects. Therefore, the IRB Coordinator must maintain current knowledge of OHRP and FDA regulations, NIH Guidelines and BRANY IRB Standard Operating Procedures, as well as current guidance in human subject protections, GCP, and AAHRPP accreditation standards. Maintenance of this knowledge will be accomplished via continuing education conducted at IRB team meetings, and/or applicable professional meetings or educational seminars/programs attended.
2. Evaluates submissions to the IRB for completeness, accuracy, and applicable required components based on submission type.
3. Determines level of IRB review required. Prepares and processes submissions for IRB review, including preparation of reviewer checklists, managing materials reviewed by IRB, and maintaining IRBManager events and records.
4. Ability to communicate with researchers, committee members, consultants and other research professionals regarding regulatory requirements, protocol design, consent, HIPAA, and other research study requirements.
5. Attend IRB meetings and ensure that for all items on the IRB meeting agenda the required regulatory determinations are considered, and committee questions are addressed sufficiently to facilitate the IRB’s decision and voting.
6. Serves as a resource for assigning IRB reviewers.
7. Ensures that investigators, sponsors/CROs and applicable Clinical Trials Activation Team (CTAT). members are advised of IRB decisions in writing within established timelines for submission type.
8. Implements directed changes to consent forms, assent forms or other materials when requested by IRB reviewers and ensures proper re-review as needed (i.e. IRB review of revisions required by the IRB to secure approval, either by expedited or convened IRB review).
9. Prepares weekly and monthly submission reports, analyzing submissions and including a recommended action plan to move submissions forward within or under the established time frame target for the submission type.
10. Manages submissions to ensure efficient interaction between IRB reviewers and IRB staff. Provides feedback to supervisor(s) regarding the IRB submissions and offers suggestions for changes or improvements as necessary.
11. Properly processes assigned IRB submissions, recognizing the turnaround time targets, and with attention to detail. Updates relevant parties, databases and Excel spreadsheets once approval has been issued.
12. Maintain and update information in BRANY computer databases (IRBManager, SMART, etc.) as applicable. Follow up on pending events in IRBManager to ensure the program runs more efficiently. Assist with implementation of database revisions/enhancements as needed.
13. Able to manage multiple projects with varying deadlines and changing requirements.
14. Attend webinars, and conferences in order to remain updated on trends in human research protection and the application of federal regulations and guidance.
15. Trains and develops new or inexperienced BRANY or IRB staff.
16. Assists Director of the IRB or Department staff in other activities as needed.
17. Uses communication skills to establish and maintain good working relationships with IRB members, doctors, site liaisons, investigators, CRO representatives, and sponsors.
18. Uses writing skills to effectively communicate via email and written correspondence.
19. Works independently, takes initiative and troubleshoot daily routine problems as they occur. Develop or recommend a plan of corrective action for complex non-routine issues.
20. Works as a team member on special nonrecurring and ongoing projects. (*)

Non-Essential Functions will be noted by asterisk (*).

Qualifications

Education required:

Bachelor’s Degree or equivalent experience. Science or Health related degree preferred.

Experience Required:

2 years’ experience working for an institutional review board or related research field.

Qualifications:

Familiar with FDA regulations, OHRP and GCP practices. Microsoft Office at the intermediate level or above. Currently holds Certified IRB Professional (CIP) certification or is willing to obtain CIP after meeting minimum requirements to take CIP exam.

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:

$60,000 - $65,000/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