Clinical Research Coordinator II-Radiation Oncology
Job Description
The Department of Radiation Oncology at The Mount Sinai Hospital is seeking a highly motivated Clinical Research Coordinator II (CRC II) to join our growing research team. This position offers an exciting opportunity to contribute to cutting-edge cancer research within a nationally recognized academic medical center and NCI-designated Comprehensive Cancer Center.
We are looking for an organized, detail-oriented, and compassionate individual with strong communication and interpersonal skills. The ideal candidate will be comfortable working with a large, multicultural, and ethnically diverse patient population and will demonstrate empathy, professionalism, patience, and sound judgment when interacting with patients undergoing cancer treatment. Fluency in Spanish is preferred but not required.
Candidates should have prior clinical research experience and a strong interest in oncology research. We are seeking individuals who are committed to professional growth. This position offers substantial exposure to clinical trial operations, regulatory affairs, data management, patient-facing research activities, and multidisciplinary cancer care within a leading academic medical center.
About the Department
The Tisch Cancer Institute (TCI) is a vital component of the Icahn School of Medicine at Mount Sinai and plays a key role within the Mount Sinai Health System, one of the largest healthcare systems in the nation. TCI is an NCI-designated Comprehensive Cancer Center dedicated to advancing cancer prevention, diagnosis, treatment, and survivorship through innovative research and patient-centered care.
The Department of Radiation Oncology works closely with TCI and its Cancer Research Support Unit (CRSU) to provide the infrastructure, expertise, and resources necessary to support patient-based cancer research. The department maintains an active clinical research portfolio that includes National Cancer Institute (NCI)-sponsored trials, cooperative group studies, industry-sponsored clinical trials, investigator-initiated research, translational studies, and quality-of-life research.
The CRC II will work closely with physicians, research nurses, medical physicists, sponsors, and other clinical research professionals while gaining valuable experience in the conduct and management of oncology clinical trials. With comprehensive training and mentorship, the CRC II will assume responsibility for coordinating clinical research studies of increasing complexity and significance.
Responsibilities
Primary Responsibilities
Clinical Trial Coordination
- Coordinate day-to-day activities for clinical research studies conducted within the Department of Radiation Oncology.
- Assist with study-related activities including participant outreach, scheduling, screening, and subject registration with sponsoring agencies.
- Screen potential participants for eligibility according to protocol-specific criteria.
- Obtain informed consent under investigator supervision and educate participants regarding study requirements and procedures.
- Serve as a primary point of contact for study participants throughout their research experience, providing education, support, and coordination of study-related activities.
- Conduct patient interviews and administer study-related questionnaires addressing quality of life, symptom burden, social support, mental health, cognitive function, physical mobility, and related topics.
- Coordinate protocol-required procedures, laboratory testing, imaging studies, and follow-up visits.
- Collect, process, track, and ship biological specimens, imaging studies, and other protocol-required materials.
- Ensure protocol compliance and coordinate study activities with investigators, clinical staff, and ancillary departments.
- Serve as a liaison among investigators, study participants, sponsors, and institutional departments.
- Assist in safeguarding participant rights and ensuring adherence to ethical research practices.
- Manage and track participant reimbursement and study-related compensation when applicable.
- Develop expertise in the management of oncology clinical trials, including NCI-sponsored, cooperative group, industry-sponsored, and investigator-initiated studies.
Data Management and Study Oversight
- Conduct detailed electronic medical record reviews and abstract clinical data.
- Ensure accurate and complete compilation of subject data through electronic chart reviews and source documentation review.
- Collect, enter, and maintain accurate study data within case report forms (CRFs), electronic data capture systems, REDCap databases, and institutional databases.
- Ensure timely and accurate submission of study data according to protocol and sponsor requirements.
- Maintain complete and compliant source documentation, regulatory files, and subject records.
- Prepare for and participate in sponsor monitoring visits, audits, and quality assurance reviews.
- Meet with internal and sponsor-appointed monitors to ensure accuracy of subject data and compliance with research protocols.
- Assist investigators with data reporting, analysis, and study-related documentation as needed.
Regulatory Compliance
- Assist with the preparation and maintenance of regulatory submissions, including new protocols, amendments, continuing reviews, and study closures.
- Report adverse events and serious adverse events in accordance with institutional policies, sponsor requirements, Good Clinical Practice (GCP), and federal regulations.
- Ensure compliance with Institutional Review Board (IRB), sponsor, and regulatory requirements.
- Coordinate translation of study documents and informed consent forms when required.
- Assist investigators and regulatory staff with protocol implementation and ongoing regulatory maintenance.
- Additional Responsibilities
- Participate in Study Initiation Visits (SIVs), investigator meetings, sponsor training sessions, and site qualification visits.
- Attend departmental, institutional, and sponsor-required educational programs and training activities.
- Communicate with internal and external healthcare providers to obtain study-related documentation and long-term follow-up information.
- Assist in training and mentoring new research staff on study procedures, patient registration, data management, and specimen handling.
- Participate in professional development activities designed to enhance clinical research, regulatory, and oncology-specific knowledge.
- Contribute to the continued growth and success of the Department's clinical research program.
- Perform other research-related duties as assigned.
Qualifications
- Bachelor's degree required; Master's degree in a scientific, health-related, or research field preferred.
- Minimum of two years of experience in Clinical Research in roles such as Clinical Research Coordinator, Study Coordinator, Data Manager, Research Assistant, or related clinical research position
- Experience working in a healthcare, academic medical center, or clinical research environment preferred
- Oncology clinical research experience preferred
- Working knowledge of Good Clinical Practice (GCP), human subject?s protections, and federal research regulations preferred
- Experience with electronic medical records and clinical research databases preferred.
- Excellent written, verbal, and interpersonal communication skills.
- Strong organizational skills with the ability to manage multiple studies and competing priorities.
- Exceptional attention to detail and commitment to data quality.
- Ability to establish rapport with patients undergoing cancer treatment and their families.
- Professional demeanor and ability to interact effectively with physicians, nurses, sponsors, and research staff.
- Comfortable communicating clinical information to healthcare professionals and research stakeholders.
- Strong computer proficiency, including Microsoft Office applications and electronic medical record systems.
- Ability to work independently while functioning effectively as part of a multidisciplinary team.
- Spanish language proficiency preferred.
Non-Bargaining Unit, 861 - Radiation Oncology - ISM, Icahn School of Medicine
About Us
Strength through Unity and Inclusion
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 Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.
About the Mount Sinai Health System:
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 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, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
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, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.