Required Qualifications: (As Evidenced by an Attached Resume)
Bachelor’s Degree. One (1) year of full time research experience and/or Healthcare administrative experience. Candidate must have excellent writing skills, verbal communication and be highly organized.
Master’s Degree. Familiarity with FDA procedures and regulations pertaining to writing, filing, obtaining and maintaining approval of Investigational New Drug applications.Advanced degree in the biomedical/health sciences. Investigational New Drug application experience specifically for Positron Emission Tomography (PET) radiotracers. Preparation and submission of long term follow up reports and IND annual reports to the FDA, IRB, and DSMB. Experience with clinical research studies
Brief Description of Duties:
The Investigational New Drug (IND) Coordinator will assemble and write appropriate sections of Investigational New Drug applications specifically for Positron Emission Tomography (PET) radiotracers that will be used in research PET imaging of human research volunteer subjects, and will also play an important role in fulfilling the reporting requirements and participating in discussions with regulatory agencies. The successful candidate will work closely with the radiochemist, the principal investigators of the studies and all others providing materials for each IND application. The incumbent must have, or quickly develop, expert knowledge of the application process, the relevant regulatory requirements, and contacts at the FDA involved in the filing process.
- Assembles and writes appropriate sections of Investigational New Drug applications specifically for Positron Emission Tomography (PET) radiotracers that will be used in research PET imaging of human research volunteer subjects.
- Coordinates all tasks with the Director of the PET Center and the Director of PET Research.
- Develops expert knowledge of the application process, the relevant regulatory requirements, and contacts at the FDA involved in the filing process.
- Fulfills the reporting requirements and participating in discussions with regulatory agencies.
- Works closely with the radiochemist, the principal investigators of the studies and all others providing materials for each IND application.
- Facilitates preparation and submission of long term follow up reports and IND annual reports to the FDA, IRB, and DSMB.
- Provides information on regulatory issues to Principal Investigators (PI) in planning stages of PET imaging studies involving radiotracers that will require IND submissions.
- Serves as main FDA liaison for the PET researchers planning or performing studies utilizing tracers authorized under INDs.
- Prepares monitoring plan template and ensure appropriate monitoring is planned for all IND-based PET imaging studies.
- Assists principal investigators in reporting of Adverse Events (AE) and Serious Adverse Events (SAE) to regulatory agencies.
- Coordinates the education and training of key personnel of the study to ensure adherence to schedules of required reports, SAE reporting and the collection of data and maintenance of records.
- Prepares materials needed for internal and/or external audits of protocols using radiotracers authorized under IND jurisdiction. Direct participation in audits.
- Other duties or projects as assigned as appropriate to rank and departmental mission.
FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain the FLSA exemption.
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Official Job Title: Project Staff Assistant
Job Field: Administrative & Professional (non-Clinical)
Primary Location: US-NY-Stony Brook
Department/Hiring Area: Psychiatry-The Research Foundation for The State University of New York at Stony Brook
Schedule: Full-time Day Shift 8:30-5Psychiatry-The Research Foundation for The State University of New York at Stony Brook
Posting Start Date: Jul 11, 2017
Posting End Date: Jul 25, 2017, 10:59:00 PM
Salary: $55,000-$70,000 / Annual @ 1.0 FTE CWE
Salary Grade: E99