Mount Sinai Careers
Clinical Research Coordinator II, Cancer Institute
Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
The clinical research professional works closely
with physicians, research participants, and administrative staff in the
execution, conduct, and overall management of the Bone Marrow Transplant
clinical research portfolio of trials. This integral member of the team works
under the direction of the principal investigator (PI). The BMT portfolio of
trials includes National Cancer Institute (NCI), pharmaceutical company,
cooperative group, and investigator-initiated clinical trials. You are responsible
for coordinating complex cancer clinical trials. Effective oral and written
communication skills are essential.
Roles & Responsibilities:
- Coordinates all activities of ongoing clinical trials
- 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
- Manages study data of ongoing clinical trials, alone or in conjunction with non-nurse research coordinators
- Ensure accurate and complete compilation of subject data through chart reviews
- Collect and record study data on Case Report Forms 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 Icahn School of Medicine at Mount Sinai (ISMMS) standard operating procedures (SOPs)
- Analyze data with investigators as needed
- Ensures proper compliance with institutional and national regulatory requirements
- Report adverse events and serious adverse events in accordance with ISMMS 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
- Participate in Investigators Meeting and coordinate Study Initiation Visits
- Attend divisional/departmental/institutional educational and training seminars
- Contact local physicians to obtain source
documentation and subject survival status
Mentor/Educate New Staff-Educate new staff regarding overview of clinical research, office policy and procedures, data submission, patient registration and specimen handling.
- Bachelor’s Degree in science related field preferred
- Minimum Experience Required: 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
- Demonstrate strong organizational and communication skills
- Oncology experience preferred
- Must be comfortable communicating clinical information to medical personnel
- Strong computer literacy required.
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!
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 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.