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Dept- 015 Tisch Cancer Institute REQ #2532168
Job Title: Data Entry Specialist II
A Data Entry Specialist II position is currently available within the Tisch Cancer Institute, Cancer Clinical Trials Office for the Novel Therapeutics Program (NTP). The Data Entry Specialist will maintain essential study documents for clinical research studies, enter data onto Case Report Forms, and ensure study compliance for the NTP Oncology team. The submission of clinical trial data of research studies will be under the medical supervision of a Principal Investigator (PI) and the Cancer Clinical Trials Office.
Additional duties include maintaining data bases such as data entry of confidential patient information within designated time frames, preparing informed consent forms and other necessary documentation for signature, reports, and annual updates for the Institutional Review Board and other oversight bodies related to the study.
The Tisch Cancer Institute is a vital component of the Icahn School of Medicine at Mount Sinai Hospital and plays a key role in the Mount Sinai Health System, which is one of the largest health care systems in the nation. We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer.
- Work in collaboration with other research team members including but not limited to Principal Investigators, Clinical Research Coordinators, Clinical Research Nurses, Sponsors, Contract Research Organizations
- Assist in study related sponsor visits up including, but not limited to Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, Close-Out Visits, Internal Audits, and Sponsor Audits.
- Compares schedule of events to Case Report Form (CRF) in order to correctly capture study specific data points on the CRFs.
- Records accurate data by completing paper or electronic CRFs. Keeping and maintaining of paper files as required.
- Resolves data queries accurately and within study specific timeframes.
- Responds to data queries in a timely manner.
- Maintains timely patient follow-up by accurately reviewing the study specific follow-up schedule in the protocol and completes follow-up CRFs.
- Report, track, and file off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB) within the required time frame dictated by the IRB of record.
- Utilizes the SAE reporting log to track the receipt, submission and acknowledgement of off-site SAEs per protocol.
- Prepare reports, including but not limited to screening and enrollment logs.
- Ability to sit and concentrate at a computer workstation.
- Performs other related duties as assigned.
- Bachelor's degree or minimum of 1 year experience in research that includes data abstracting, case report form completion and regulatory reporting.