Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
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.
Roles & Responsibilities:
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.
Strength Through Diversity
The Mount Sinai Health System believes that diversity is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize medicine together.
We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
Who We Are
Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression.