Clinical Research Coordinator II - Medical Clinical Trials Office

A Clinical Research Coordinator (CRC) II position is currently available within the Medicine Clinical Trials Office. 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.

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, administering lifestyle questionnaires. 
• Obtain informed consent under supervision of the study investigator(s) 
• Educate potential participants regarding study requirements
• Screen patients for eligibility though through medical record review 
• 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 study sponsor. 
• 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). 
• Oversee subject recruitment and study enrollment goals. Determine effective strategies for recruiting research participants and retaining participants in long-term clinical trials.
• Assist with analyzing data as needed

Ensure proper compliance with institutional and 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 
• Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol. 
• Regularly inspect study document to ensure ongoing regulatory compliance. The coordinator will also comply with necessary regulatory responsibilities. 

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. 
• Facilitate sponsor monitoring visits. 
• Educate new staff regarding overview of clinical research, office policy and procedures, data submission, workflows and specimen handling. 
• Under the supervision of the clinical research manager, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings.

• Bachelors degree in sciences or related field.
• 2 years of clinical research

Compensation Statement

The Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for this role is $60,420.83 - $80,000.09 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

Non-Bargaining Unit, ICG - Medicine MCTO - ISM, Icahn School of Medicine

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. 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 invite you to participate actively as a part of th