Track and log instances of non-compliance and audit action items
Benefits
Comprehensive health insurance options
Retirement savings plan with employer match
Generous paid time off and holiday schedule
Professional development opportunities
Supportive work environment fostering collaboration
Full Job Description
Position Summary:
We have an exciting opportunity to join our team as a Scientific Research Manager (IRB).
Reporting to the Associate Director of the IRB, the Scientific Manager I (SM-I) is responsible for overseeing the efficient operation of all processes related to post approval expedited submission action items (projects having already received initial approval by the IRB) and acts as the primary liaison with the relevant investigators. SM-I is responsible for the management of all expedited submission action items and the post approval expedited team. The SRM-I must ensure that post approval expedited items are processed within the expected turn around time. The SRM I will also provide vacation and sick leave coverage for SSRM and SRM-II
Job Responsibilities:
Oversee the day-to-day operations of all full board submissions
Conduct scientific, ethical and regulatory oversight of full board submissions to:
Ensure completeness and accuracy of information and required documentation by using the appropriate review checklists.
Ensure the protocol and other relevant documents are in compliance with NYU SoM Policies & procedures, federal, state and local law, as well as good clinical practices.
Determine whether the submission requires an IND/IDE
Perform final review and make final determination of a submission `readiness for all new protocols, continuations, amendments before board assignment is made
Review of all initial full board agenda items in preparation for meetings of Boards A, B, C, D, F, and G
Make final determination on all submissions that qualify for expedited review and liaise with appropriate HRP Staff to ensure appropriate review
Conduct comprehensive pre-review of reportable events and make determinations based on the NYU SOM RNI policy
Lead prebriefings with IRB staff and IRB Chair to ensure any outstanding deficiencies are discussed and addressed, and any findings that need to be made at the IRB meeting are communicated to the Chair.
Lead debriefings following each board meetings to verify staffs understanding of the boards determinations to be used to generate minutes and letters
Attend Board E compliance meetings, take meeting minutes, and manages post-review responsibilities.
Create and send audit board determination letters, including findings of non-compliance, serious or continuing non-compliance, and study suspension
Created any board correspondence regarding non-compliance in a timely manner and works with the Senior Director, HRP, Office of General Counsel and NYC Health + Hospitals (as applicable) to ensure accuracy of information before letters are finalized.
Manages dissemination of the board letters regarding non-compliance that require reporting to Federal Agencies and ensures timely reporting to Federal to the Principal Investigator, Institutional Leadership and the Federal government ,OHRP, FDA and other agencies as needed.
Maintain a detailed log of all instances of non-compliance, UAPs, federal correspondence, allegations of non-compliance, and audit / RNI action items.
Conduct regular follow up with PIs on all outstanding issues resulting audit board determinations
Oversee responses to deferrals and assess readiness for re-review by the IRB
Write and relay concise response review issues to PI through Research Navigator
Ensure all communications with research teams are recorded in Research Navigator
Manage all aspects of IRB meetings, including attending each meeting, meeting minutes, and post-review decisions to final outcome of all agenda items.
Manage compliance related board determination letters, including findings of non-compliance, serious or continuing non-compliance, and study suspension
Maintain the non-compliance log and track all instances of non-compliance, UAPs, federal correspondence, allegations of non-compliance, and audit / RNI action items to completeion .
Manage assignment of primary reviewers for full board protocol review while ensuring that protocols are distributed in an equitable and specialty-specific manner. Verify the absence of reviewers conflicts
Ensure all controverted issues and their resolution and Board determinations are recorded in IRB meeting minutes
Oversee debriefings following Board meetings to verify understanding of the determinations
Generate and issue all board determination (deferral, modifications required, and approval) letters for initial submissions, documenting all IRB determinations
Review all board determination (deferral, modifications required, and approval) letters for modification and continuation submissions prior to release by Senior Analyst
Attend all board meetings as a voting member, and work with IRB Chair to manage each Board meeting to ensure regulatory findings are made and appropriate for each full board submission.
Lead prebriefings with IRB staff and IRB Chair to ensure any outstanding deficiencies are discussed and addressed, and any findings that need to be made at the IRB meeting are communicated to the Chair.
Develop, generate and distribute meeting minutes to the Associate Director for pre-review, prior to distribution to the Chair, Sr. HRP Director, and appropriate Board for review and approval
Oversee outstanding issues resulting from Deferrals of new studies and follow up with PI to ensure completion.
Oversee elements of the meeting agenda and assign reviewers when required
Provide guidance and training to the Full Board IRB staff to educate and assist them in IRB submission activities
Performs designated review for submissions that qualify for review under expedited procedures
Performs review and designated review of responses to conditional approvals.
Performs Full Board new study reviews from submission to approval when required
Work with Associate Director on regular Quality Control reviews, twice a year
Develop power point presentations and participate in education and training sessions for research community, IRB staff, and IRB members. This will require working with IRB Education Manager
Provide coverage of aspects of other managers responsibilities when the manager is not available; agenda, review of letters, interact and direct staff and communicate with research teams to resolve issues related to IRB determinations
Provide support and assistance for any additional work as required by the Associate Director
Minimum Qualifications:
Must have an advanced degree;
Solid command of human subject regulations and policy;
Must exercise a high degree of independent judgment and discretion relating to research protocol issues;
Superior organizational, analytical, time management, multi-tasking and interpersonal communication skills required;
Excellent verbal and technical writing skills and proficient use of computer and relevant software and database applications (IRB Software, MS Word, PowerPoint, etc.).
CERTIFICATIONS:Certified IRB Professional (CIP) required (or will be required within 1 year of employment) and Clinical Research Coordinator (CCRC)
Preferred Qualifications:
Clinical Research Coordinator (CCRC) preferred
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $84,577.92 - $108,675.87 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.
To view the Pay Transparency Notice, please click here
About NYU Langone Health
NYU Langone Health is a health care system that includes hospitals, outpatient centers, and primary care offices throughout the New York City area. The system is affiliated with the New York University School of Medicine and is known for its expertise in areas such as cardiology, neurology, and oncology. NYU Langone Health employs over 35,000 people and has a network of more than 350 outpatient locations. The system was founded in 1841 and is headquartered in New York, New York.
