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Dept- Tisch 015 REQ # 2589942
Job Title: Clinical Research Coordinator II
- A Clinical Research Coordinator (CRC) II position is currently available within the Tisch Cancer Institute. Duties will include activities such as data collection and management of patient clinical information, timely collection of protocol related samples including shipment to outside entities as required, obtain informed consent, collect, maintain and organize study information, and assist with other day-to-day operations as required. Under minimal supervision, the Clinical Research Coordinator II will manage a workload that includes studies of increased complexity.
- 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.
- Coordinates activities of ongoing clinical trials:
- Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
- Obtain informed consent under supervision of the study investigator(s); educate participants regarding study requirements.
- Screen patients for eligibility and register subjects with sponsoring agency.
- Coordinate research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing.
- Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol.
- Act as liaison between investigator(s) and sponsoring agency.
- Coordinate activities pertinent to the safeguarding of patients’ rights in research.
- Manage study data of ongoing clinical trials under supervision of the Principle Investigator(s):
- Ensure accurate and complete compilation of subject data through chart reviews.
- Collect and record study data on Case Report Forms (CRFs) and submit forms in a timely manner according to study guidelines.
- Meet with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol.
- Maintain source documents and subject files in accordance with Mount Sinai School of Medicine (MSSM) Standard Operating Procedures (SOPs).
- Assist with analyzing data as needed.
- Ensure proper compliance with institutional and national regulatory requirements
- Report adverse events and serious adverse events in accordance with MSSM Institutional Review Board (IRB) SOPs, sponsor guidelines, and federal regulations
- Assist the PI and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials
- Performs other job related duties as required, which may include but not limited to:
- Participate in Investigators’ Meeting and assist with coordinating Study Initiation Visits.
- Attend divisional/departmental/institutional educational and training seminars.
- Contact local physicians to obtain source documentation and subject survival status.
- Educate new staff regarding overview of clinical research, office policy and procedures, data submission, patient registration and specimen handling.
- Bachelors’ degree in science or related field.
- At least 2 years’ experience as a Clinical Research Coordinator, Study Coordinator, Data Manager, or similar role in clinical research.
- Working knowledge Good Clinical Practice guidelines and Federal research regulations.
Skills and Abilities:
- Demonstrate strong organizational and communication skills.
- Oncology experience preferred.
- Must be comfortable communicating clinical information to medical personnel.
- Strong computer literacy required.