Position Summary

At Stony Brook Medicine, a TH Instructional Support Assistant/Cancer Clinical Trials Sr. Data Coordinato r is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior communication and organization skills while adhering to our high standard of excellence

Duties may include but are not limited to the following:

• Assist with the submission of protocols, amendments, notices and terminations to the Institutional Review Board (IRB), regulatory agencies and sponsors for review and approval.
• Assists with reporting all adverse drug reactions to the Federal Drug Administration (FDA), National Cancer Institute (NCI), Oncology Cooperative Groups, IRB and sponsoring drug companies.
• Participates in the initiation of studies with pharmaceutical companies and cooperative groups.
• Chart review and data collection of patient medical records and creation of clinical record charts. Completion of data case report forms both paper and electronic.
• Assist in the data entry and monitoring of databases for the collection of data.
• Ensures appropriate patient follow-up as required by protocol.
• As the Sr. Data Coordinator, will be responsible for the oversight of all databases maintained by the Cancer Clinicial Trials Office by ensuring all office database entries are entered timely and accurately, using methods such as cross referencing the various database forums used within the office and studies.
• Prepares reports regarding databases for the Cancer Center Clinicial Trials Administrative Directors' review.
• Other duties as assigned by supervisor.

Qualifications

Required : Associates Degree. In lieu of degree a combination of directly related experience and education totaling 4 years may be considered. One year full time experience in a clinical setting with basic fundamental knowledge of medical and scientific terminology. Excellent organizational and communication skills (both verbal and written). Computer skills. Knowledge of Electronic Data Capturing (EDC) databases including, but not limited to systems like Medidata, RAVE, RedCap and OnCore.

Preferred : Additional years of experience working in a clinical setting. Experience with clinical trials and the IRB regulatory process. Previous work history relating to Oncology. IRB training.

• Stony Brook Medicine is a smoke free environment. Smoking is strictly prohibited anywhere on campus, including parking lots and outdoor areas on the premises.
• All Hospital positions maybe subject to changes in pass days and shifts as necessary.
• This position may require the wearing of respiratory protection, which may prohibit the wearing of facial hair.
• This function/position maybe designated as "essential." This means that when the Hospital is faced with an institutional emergency, employees in such positions may be required to remain at their work location or to report to work to protect, recover, and continue operations at Stony Brook Medicine, Stony Brook University Hospital and related facilities.

• Successfully complete pre-employment physical examination and obtain medical clearance from Stony Brook Medicine's Employee Health Services*
• Complete electronic reference check with a minimum of three (3) professional references.
• Successfully complete a 5 panel drug screen*
• Successfully complete a Background Check investigation.
• Provide a copy of any required New York State license(s)/certificate(s).