MOUNT SINAI MORNINGSIDE
Senior Clinical Research Coordinator - Tisch Cancer Institute
MOUNT SINAI MORNINGSIDE, New York, New York, us, 10261
Overview
Senior Clinical Research Coordinator - Tisch Cancer Institute at Mount Sinai Morningside A Senior Clinical Research Coordinator position is available within the Tisch Cancer Institute. The Senior Clinical Research Coordinator will work with Principal Investigators (PIs), Research Manager and Clinical Research Team to manage data associated with cancer clinical research protocols. Under general supervision, analyzes and interprets highly complex clinical research data; conducts clinical testing and develops protocols. Develops work flow policies and procedures. Mentors, trains and reviews the work of less experienced clinical research staff. Oversees the clinical assessments of the study subjects. Assists with protocol submissions, database enhancements, and budget preparation. 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. We are an NCI-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs. Responsibilities
Participate in Clinical Trial Feasibility, Site Selection Process and Site Initiation Visit. Portfolio will include but not limited to complex, first-in-human Phase 1 and Phase 2 trials. Coordinate patient care with ancillary departments such as pathology, interventional radiology, immune monitoring core, clinical laboratory, surgery, stem cell lab, transplant team and clinical services including RTC, and inpatient floors. Pre-Screen patients by conducting Medical Records review. With input from PIs and Research RNs, create and maintain Standard Operating Procedures (SOPs) specific for each study. Coordinate the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects. Prompt PIs and Research Team including Research RNs about protocol requirements for upcoming study visits. Collect required data and maintain the data management database. Design specific projects data sets, including the selection of appropriate methods and techniques to capture in case report forms. Track and maintain Investigator New Drug Safety Reports and identify trends in adverse events. Assist in preparing and ensuring that grant applications and IRB/GCO documents are submitted. Coordinate protocols and human subject approvals between various sites. Assist the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials. Mentor, train and review the work of CRC I and CRC II and CRC at other sites for multi-center trials. Develop workflows and policies for assigned trials. Prepare reports for presentation in conferences and seminars. Oversee data collection, processing, storage, inventory and quality control for clinical research studies. Assist in budget preparation and negotiation and ensure research billing compliance. Prepare and participate in external audits including FDA audits. Perform other duties assigned. Qualifications
Bachelors degree in sciences or related field. Masters degree preferred 5 years of clinical research; oncology experience is preferred Excellent written and oral communication skills Exceptional attention to detail and accuracy Ability to manage multiple tasks & priorities Demonstrated leadership potential Employer Description
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinais legacy of achievement, education, and innovation. Equal Opportunity Employer The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. Compensation
The salary range for the role is $70,077.82 - $116,693 Annually. Actual salaries depend on experience, education, and operational need. This range does not include bonuses or other forms of compensation. #J-18808-Ljbffr
Senior Clinical Research Coordinator - Tisch Cancer Institute at Mount Sinai Morningside A Senior Clinical Research Coordinator position is available within the Tisch Cancer Institute. The Senior Clinical Research Coordinator will work with Principal Investigators (PIs), Research Manager and Clinical Research Team to manage data associated with cancer clinical research protocols. Under general supervision, analyzes and interprets highly complex clinical research data; conducts clinical testing and develops protocols. Develops work flow policies and procedures. Mentors, trains and reviews the work of less experienced clinical research staff. Oversees the clinical assessments of the study subjects. Assists with protocol submissions, database enhancements, and budget preparation. 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. We are an NCI-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs. Responsibilities
Participate in Clinical Trial Feasibility, Site Selection Process and Site Initiation Visit. Portfolio will include but not limited to complex, first-in-human Phase 1 and Phase 2 trials. Coordinate patient care with ancillary departments such as pathology, interventional radiology, immune monitoring core, clinical laboratory, surgery, stem cell lab, transplant team and clinical services including RTC, and inpatient floors. Pre-Screen patients by conducting Medical Records review. With input from PIs and Research RNs, create and maintain Standard Operating Procedures (SOPs) specific for each study. Coordinate the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects. Prompt PIs and Research Team including Research RNs about protocol requirements for upcoming study visits. Collect required data and maintain the data management database. Design specific projects data sets, including the selection of appropriate methods and techniques to capture in case report forms. Track and maintain Investigator New Drug Safety Reports and identify trends in adverse events. Assist in preparing and ensuring that grant applications and IRB/GCO documents are submitted. Coordinate protocols and human subject approvals between various sites. Assist the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials. Mentor, train and review the work of CRC I and CRC II and CRC at other sites for multi-center trials. Develop workflows and policies for assigned trials. Prepare reports for presentation in conferences and seminars. Oversee data collection, processing, storage, inventory and quality control for clinical research studies. Assist in budget preparation and negotiation and ensure research billing compliance. Prepare and participate in external audits including FDA audits. Perform other duties assigned. Qualifications
Bachelors degree in sciences or related field. Masters degree preferred 5 years of clinical research; oncology experience is preferred Excellent written and oral communication skills Exceptional attention to detail and accuracy Ability to manage multiple tasks & priorities Demonstrated leadership potential Employer Description
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinais legacy of achievement, education, and innovation. Equal Opportunity Employer The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. Compensation
The salary range for the role is $70,077.82 - $116,693 Annually. Actual salaries depend on experience, education, and operational need. This range does not include bonuses or other forms of compensation. #J-18808-Ljbffr