Clinical Research Coordinator II - Medicine Clinical Trials Office

About the role

The Clinical Research Coordinator (CRC) II position is available within the Medicine Clinical Trials Office. Under minimal supervision, this role coordinates clinical assessments of study subjects, analyzes and assists in interpreting moderately complex clinical research data, and prepares grant applications and protocol submissions (e.g., Institutional Review Board, Grants and Contracts Office). The CRC II manages studies of increased complexity and supports day-to-day operations of clinical trials.

Responsibilities

• Coordinates activities of ongoing clinical trials, including:
  • Answering phone calls and screening participants for eligibility.
  • Administering lifestyle questionnaires.
  • Obtaining informed consent under the supervision of study investigators.
  • Educating potential participants regarding study requirements.
  • Screening patients for eligibility through medical record review.
  • Coordinating the research team to ensure compliance with the planned treatment protocol, including required laboratory and radiographic testing.
  • Securing, delivering, and shipping blood, tissue samples, radiographs, and other clinical specimens as required by protocol.
• Acts as a liaison between investigators and study sponsors.
• Coordinates activities to safeguard patients’ rights in research.
• Manages study data under the supervision of the Principal Investigator(s):
  • Ensures accurate and complete compilation of subject data through chart reviews.
  • Collects and records study data on Case Report Forms (CRFs) and submits forms in a timely manner according to study guidelines.
  • Meets with internal and sponsor-appointed monitors to ensure accuracy of subject data and compliance with research protocol.
  • Maintains source documents and subject files in accordance with Mount Sinai School of Medicine (MSSM) Standard Operating Procedures (SOPs).
  • Oversees subject recruitment and study enrollment goals.
  • Determines effective strategies for recruiting and retaining participants in long-term clinical trials.
  • Assists with analyzing data as needed.
• Ensures compliance with institutional and regulatory requirements:
  • Reports adverse events and serious adverse events in accordance with MSSM IRB SOPs, sponsor guidelines, and federal regulations.
  • Assists the Principal Investigator and regulatory staff in preparing new protocol submissions, amendments, and renewals.
  • Interacts with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
  • Regularly inspects study documents to ensure ongoing regulatory compliance.
• Performs other job-related duties, including:
  • Participating in Investigators’ Meetings and coordinating Study Initiation Visits.
  • Attending divisional, departmental, and institutional educational and training seminars.
  • Facilitating sponsor monitoring visits.
  • Educating new staff on clinical research overview, office policies, data submission, workflows, and specimen handling.
  • Maintaining procedures for timely and complete data management under the supervision of the clinical research manager.

Requirements

• Bachelor’s degree in sciences or a related field.
• 2 years of clinical research experience.

Skills

• Preferred working knowledge of Good Clinical Practice guidelines and Federal research regulations.
• Strong understanding and knowledge of coordination requirements for industry-funded clinical trials.
• Demonstrated strong organizational and communication skills.
• Comfortable communicating clinical information to medical personnel.
• Proven organizational skills, including attention to detail and multi-tasking.
• Ability to work within a team environment as well as independently.
• Ability to identify, analyze, and solve problems while working under pressure.
• Strong computer literacy.

About the employer

The Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with over 48,000 employees across eight hospitals, more than 400 outpatient practices, 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people by tackling complex healthcare challenges through innovation, research, and education. The system integrates hospitals, labs, and schools to deliver comprehensive care from birth through geriatrics, leveraging advanced approaches like artificial intelligence and informatics while prioritizing patients' medical and emotional needs.

Mount Sinai is consistently ranked among the top hospitals by U.S. News & World Report, including high "Honor Roll" status, and is recognized for excellence in specialties such as geriatrics, cardiology, endocrinology, neurology, orthopedics, and more. The Icahn School of Medicine at Mount Sinai is a leader in National Institutes of Health funding and research innovation.

The Mount Sinai Health System is committed to fostering an inclusive environment where everyone can contribute to excellence. The organization values diversity, equity, and inclusion, ensuring fair access to opportunities and supporting the success of every individual. Leaders at Mount Sinai are dedicated to creating a workplace where collaboration, respect, and continuous learning drive positive change for staff, patients, and the community.

Pay

The salary range for this role is $66,199.98 - $90,000.04 annually. Actual salaries depend on experience, education, and operational need. The range does not include bonuses, incentive pay, differential pay, or other forms of compensation or benefits.