Job Information
New York University Assistant Research Scientist (Clinical Research Coordinator) in New York, New York
Assistant Research Scientist (Full-Time)
NYU Dentistry Translational Research Center
The Assistant Research Scientist (Clinical Research Coordinator) 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. The candidate will also serve as the main point of contact and project manager for multi-site studies. Candidate will conduct quality management audits for various studies at the NYU College of Dentistry.
Primary point of contact for 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 weight/height/vital signs
Perform all study procedures in compliance with NIH, FDA, GCP and ICH regulations
Develop Case Report Forms (CRFs) in REDCap
Record research data in CRFs
Review 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
Maintain 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
Educational Requirements:
Applicants must have 3 - 4 years related healthcare experience or other comparable combination of education, training and experience. Background in dental hygiene or dentistry is preferable.
Specialized Certifications and Licensure:
CCRC certified or at least 3 years experience directly related to the listed duties and prepared to take CCRC certification exam
Phlebotomy skills
Clinical Research Training Experience:
Minimum of two-years of clinical research administration experience and QC/QA experience
Project management experience for multi-site studies
Competencies:
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
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
In compliance with NYC’s Pay Transparency Act, the annual base salary range for this position is $60,000 - $75,000. 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.
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.
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