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/gdprNYU 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