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Senior Clinical Research Coordinator, Cancer Institute
The Mount Sinai Health System
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The Mount Sinai Health System’s commitment to excellence extends beyond delivering world-class health care. The System’s ongoing success is dependent upon our highly motivated, nonclinical professionals working to improve business operations. Our leadership team is driven to provide exceptional service by cultivating a workforce that is dedicated to upholding Mount Sinai’s mission of delivering innovative, breakthrough medicine with compassion and integrity.
Are you ready to discover the world of limitless possibilities that comes with wearing the badge? Explore more about this opportunity and how you can help us write a new chapter in our story of unrivaled patient care!
A Senior Clinical Research Coordinator position works within the Cancer Clinical Trials Office at the Tisch Cancer Institute to support the GU Program. The Senior Clinical Research Coordinator will work with Principle Investigators (PIs), Research Manager and Clinical Research Team to manage data associated with cancer clinical research protocols.
Under minimal supervision, analyzes and interprets highly complex clinical research data. Responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. Maintains recordkeeping systems and procedures to ensure compliance with study protocol and all appropriate regulations. Articulates understanding of ICH/GCP and Federal Regulatory requirements, a technical resource for the team and assists with protocol submissions and database enhancements. Develops work flow policies and procedures. Supports, mentors, and trains the work of less experienced clinical research staff.
Duties and Responsibilities:
- Participate in Clinical Trial Feasibility, Site Selection Process and Site Initiation Visit
- Analyzes moderately complex clinical research data; Assists in interpreting Clinical research data,
- Summarizes and aggregates clinical trial and correlative data
- 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, 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.
- Coordinates 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.
- Mentors, trains and reviews the work of CRC I and CRC II and CRC at other sites for multi-center trials.
- Develops work flow policies and procedures for assigned trials.
- Prepares reports for presentation in conferences and seminars.
- Oversees data collection, processing, storage, inventory and quality control for clinical research studies. .
- Prepare and participate in external audits including FDA audits.
- Perform other duties assigned.
- Bachelor's degree in health related field. Master's degree preferred
- 3-5 years of clinical research, and oncology experience preferred
- Excellent written and oral communication skills
- Exceptional attention to detail and accuracy
- Ability to manage multiple tasks & priorities
- Demonstrated leadership potential
Do you share our dedication to extraordinary service and have what it takes to wear the badge? Apply now!
Over 35,000 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 committed to the tenets of diversity and workforce that are strengthened by the inclusion of and respect for our differences. We offer our employees a highly competitive compensation and benefits package, a 403(b) retirement plan, and much more.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.