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Clinical Research Coordinator II - Medicine Clinical Trials Office

Mount Sinai Health System · New York, NY · 1 mo ago
On-siteResearch$66k–$90k/yrFull-time

About the role

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

Responsibilities

  • Coordinates activities of ongoing clinical trials, including:
    • Answering phone calls and screening participants for eligibility.
    • Administering lifestyle questionnaires.
    • Obtaining informed consent under supervision of the study investigator(s).
    • 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.
    • Acting as liaison between investigator(s) and study sponsor.
    • Coordinating activities to safeguard patients’ rights in research.
  • Manages study data of ongoing clinical trials under supervision of the Principal Investigator(s):
    • Ensuring accurate and complete compilation of subject data through chart reviews.
    • Collecting and recording study data on Case Report Forms (CRFs) and submitting forms in a timely manner according to study guidelines.
    • Meeting with internal and sponsor-appointed monitors to ensure accuracy of subject data and compliance with research protocol.
    • Maintaining source documents and subject files in accordance with Mount Sinai School of Medicine (MSSM) Standard Operating Procedures (SOPs).
    • Overseeing subject recruitment and study enrollment goals.
    • Determining effective strategies for recruiting and retaining participants in long-term clinical trials.
    • Assisting with data analysis as needed.
  • Ensures proper compliance with institutional and regulatory requirements:
    • Reporting adverse events and serious adverse events in accordance with MSSM IRB SOPs, sponsor guidelines, and federal regulations.
    • Assisting the PI and regulatory staff in preparing new protocol submissions, amendments, and renewals of ongoing clinical trials.
    • Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
    • Regularly inspecting study documents to ensure ongoing regulatory compliance.
  • Performs other job-related duties as required, including:
    • Participating in Investigators’ Meetings and assisting with coordinating Study Initiation Visits.
    • Attending divisional, departmental, and institutional educational and training seminars.
    • Facilitating sponsor monitoring visits.
    • Educating new staff regarding clinical research overview, office policies, procedures, 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.
  • Working knowledge of Good Clinical Practice guidelines and Federal research regulations.
  • Strong understanding and knowledge base of coordination requirements associated with 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 more than 48,000 employees across eight hospitals, over 400 outpatient practices, more than 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 discovery, education, and patient-centered care.

The Health System includes more than 9,000 primary and specialty care physicians, 13 joint-venture outpatient surgery centers, and over 30 affiliated community health centers. Mount Sinai is consistently ranked among the top hospitals by U.S. News & World Report, including high "Honor Roll" status, and is highly ranked in specialties such as Geriatrics, Cardiology/Heart Surgery, Diabetes/Endocrinology, and more.

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, striving to create a workplace where all employees feel valued, respected, and empowered to grow.

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, or other forms of compensation or benefits.

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