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Clinical Research Regulatory Specialist

Clinical Research Regulatory Specialist

Job ID 
2017-10634
Campus 
Einstein/Resnick - Bronx
Posting Date 
10/30/2017
Employee Classification 
Exempt
Department 
Institutional Review Board
Position Type 
Regular Full-Time

More information about this job

ABOUT US

Founded in 1955, the Albert Einstein College of Medicine (Einstein) is one of the nation’s premier institutions for medical education, basic research and clinical investigation. A full-time faculty of some 2,000 conducts research, teaches, and delivers health care in every major biomedical specialty. The college has some 730 medical students, 193 Ph.D. students, 106 MD/Ph.D. students and 275 postdoctoral fellows.

 

Einstein’s major strength, in addition to training physicians and scientists, is its science. During fiscal year 2015, the faculty’s consistently high level of scientific achievement resulted in the awarding of more than $150 million in peer-reviewed grants from the National Institutes of Health (NIH).

 

Einstein is part of Montefiore Medicine Academic Health System, an integrated academic delivery system comprising seven campuses, including 8 hospitals, a multi-county ambulatory network, a new state-of-the art “hospital without beds”, a skilled nursing facility, school of nursing, home health agency, and the state’s first freestanding emergency department. As the University Hospital for the Albert Einstein College of Medicine, Montefiore is a premier academic health system, employing Einstein’s clinical faculty and training Einstein’s medical students, over 1,300 residents, 420 allied health students, and 1,600 nursing students annually.

 

The Albert Einstein College of Medicine is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Einstein seeks candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence, and the communities we serve. 

 

This position presents an opportunity for an individual with a commitment to the ethical conduct of research and outstanding credentials to assist with the day-to-day operations of the human research protection program at Einstein. The Einstein IRB program now includes Montefiore Medical Center. 

POSITION RESPONSIBILITIES

Responsibilities:

    • Using extensive knowledge of applicable laws and regulations the ClinicalTrials.gov Analyst must provide expert guidance on interpretation for clinical trials registration requirements including FDAAA, International Committee of Medical Journal Editors (ICMJE), Center for Medicare and Medicaid Services (CMS), and National Institutes of Health (NIH)
    • Provide guidance and support to the research community regarding the ClinicalTrials.gov database. Develop and conduct education programs and information related to Clinical Trials transparency.
    • Design and implement a communication plan for facilitating researchers’ compliance with ClinicalTrials.gov reporting requirements.
    • Provides one-on-one assistance for investigator initiated trials requiring results data entry
    • Develop, manage and update the institutional website regarding ClinicalTrials.gov
    • Using the ClinicalTrials.gov’s Protocol Review & Results System (PRS):
      • Create accounts;
      • Review, approve, and release records;
      • Provide registration assistance, as needed;
      • Contact record owners when there are problems;
      • Work with investigators to respond to problems and correct records;
      • Provide investigators with tools and resources for results reporting and one-on-one assistance, as needed.
    • Oversee internal tracking for reporting and ongoing follow-up with study teams regarding registrations and results reporting.
    • Ensure compliance with registration and results disclosure requirements, and escalate to applicable Research Compliance and/or Institutional Officials. Develop and maintain a system to prospectively identify and track studies with required results reporting. Bring retrospective studies into compliance.
    • Evaluate and monitor procedures and methods related to ClinicalTrials.gov compliance on an ongoing basis; recommend and implement new or revised procedures as needed.
    • Inform and maintain internal policies and SOP’s intended to forge institution-wide compliance with ClinicalTrials.gov. This will include the development of recommendations for corrective actions and ensuring appropriate follow-up.
    • Actively engage in the National Clinical Trials Registration Taskforce – a monthly meeting of clinical trial registration experts at Academic Medical Centers (AMC) focusing on clinical trials registration and results reporting issues that affect AMCs.
    • Initiate and participate in collaborations with key stakeholders across and outside the institution in best practices and quality improvement projects.
    • Contributes significantly to ClinicalTrials.gov-related national best practices by sharing SOPs, work processes, knowledge and experiences
    • Performs literature reviews, and keeps current on national and international policies that may affect the ClinicalTrials.gov compliance
    • Analyzes project data and prepares data for reports and presentations inside and outside the institution

QUALIFICATIONS

Experience and Educational Background:

  1. • Bachelor’s degree, preferably in one of biological or social sciences. Some statistical coursework helpful.
    • Graduate degree in a relevant field a plus.
    • 2+ years administrative experience in human subjects research related work, research compliance, quality assurance/improvement.
    • Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred or Certified IRB Professional (CIP) preferred

Skills and Competencies:

  • • Demonstrated ability to work independently on detailed analyses of complex policies, regulations, statutes and guidelines, problem solve and follow through on assignments with minimal direction.
    • Ability to communicate effectively both orally and in writing with diverse internal and external constituencies.
    • Ability to read and understand federal regulations.
    • Demonstrated administrative skills.
    • Excellent critical thinking skills.
    • Ability to liaise effectively with various departments and committees at the Institution.
    • Previous experience with educational/ compliance programs a plus.
    • Strong familiarity with Microsoft Office (Word, Windows, Excel).
    • Ability to adapt to custom web-based software and databases.
    • Ability to develop and lead educational programs, and to train groups and individuals.

Scope of Responsibility

This position will interact with investigators, administrators of several departments, members of the IRB and IRB staff. Will work with Counsel, federal regulatory affairs representatives, senior administration officials of the Dean’s Office and the MMC Compliance office.