Clinical Research Coordinator II-Radiation Oncology

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.

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.

• 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.