The incumbent will serve as the main point of contact to the principal investigator, study sponsor and IRB for multiple research studies. Candidate will be responsible for coordinating all aspects of research-related tests and procedures, including but not limited to, project implementation and start-up, development of CRFs, recruitment strategies, IRB submissions, informed consent process, collecting clinical research data and maintaining accurate regulatory binders and other study records for quality assurance.

OVERALL DUTIES AND RESPONSIBILITIES:

• Primary point of contact for the research studies

• Responsible for preparing and reviewing documents submitted to the IRB

• Recruit, screen and enroll study participants

• Administer informed consents

• Record medical history and concomitant medications

• Record patient weight/height/vital signs

• Perform all study procedures in compliance with NIH, FDA, GCP and ICH regulations

• Record research data in Case Report Forms (CRFs)

• Review patient medical / dental records

• Assess adverse events (in conjunction with PI)

• Enter data into electronic database

• Create and maintain study regulatory binders, subject files and CRFs

• Create and maintain master subject, screening/enrollment and drug accountability logs

• Collect, store, and ship lab samples

• Complete source documents

• Distribute, review and collect study diaries as appropriate

• Study-related photography

• Schedule subjects for all study visits

• Conduct QA/QC of subject charts and regulatory binders

• Prepare for monitoring and auditing visits

• Assist site staff and subjects as needed

• Assist with drafting policies and procedures as needed

In compliance with NYC’s Pay Transparency Act, the annual base salary range for this position is $47,500 - $52,500. New York University considers factors such as (but not limited to) the specific grant funding and the terms of the research grant when extending an offer.

EDUCATIONAL REQUIREMENTS:

• 1 - 2 years related healthcare experience or other comparable combination of education, training and experience. Background in dental hygiene or dentistry is preferable

SPECIALIZED CERTIFICATES/LICENSES:

• CCRC certified or at least 3 years of experience that is directly related to the listed duties or Dental hygiene license

TRAINING/EXPERIENCE CLINICAL REQUIREMENTS:

• Minimum of two-years of clinical research administration experience and QC/QA experience or other comparable combination of education, training and experience

TRANSFERABLE COMPETENCY REQUIREMENTS:

• Good writing skills

• Good verbal communications skills

• Problem-solving skills

• Works well with other team members

• Planning/organizational skills

• Personal motivation

• Project management capabilities

• Customer service skills

SPECIFIC TECHNICAL COMPETENCY REQUIREMENTS

• Knowledge of ICH/GCP guidelines for human research

• Knowledge of the Code of Federal Regulations for human subjects

• Computer competency including proficiency in Microsoft Word and Excel

• Knowledge of Phases I-IV drug development processes

• On-site and off-site study visits as required by the protocol

Qualified candidates must apply through Interfolio. Applicants must submit: 1) Cover letter / Letter of Interest; 2) Curriculum Vitae; and 3) Names and contact information of at least three professional references. To access the application, please click the "Apply Now" button located on the right.

For people in the EU, click here for information on your privacy rights under GDPR: www.nyu.edu/it/gdpr

NYU is an Equal Opportunity Employer and is committed to a policy of equal treatment and opportunity in every aspect of its recruitment and hiring process without regard to age, alienage, caregiver status, childbirth, citizenship status, color, creed, disability, domestic violence victim status, ethnicity, familial status, gender and/or gender identity or expression, marital status, military status, national origin, parental status, partnership status, predisposing genetic characteristics, pregnancy, race, religion, reproductive health decision making, sex, sexual orientation, unemployment status, veteran status, or any other legally protected basis. Women, racial and ethnic minorities, persons of minority sexual orientation or gender identity, individuals with disabilities, and veterans are encouraged to apply for vacant positions at all levels.

Sustainability Statement

NYU aims to be among the greenest urban campuses in the country and carbon neutral by 2040. Learn more at nyu.edu/sustainability