Clinical Research Coordinator II-Radiation Oncology

About the role

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.

Responsibilities

• 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.
• Capture, 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.
• Afford protection of participant rights and ensure 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.
• 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.
• Aid investigators with data reporting, analysis, and study-related documentation as needed.
• Afford assistance 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.
• Afford compliance with Institutional Review Board (IRB), sponsor, and regulatory requirements.
• Coordinate translation of study documents and informed consent forms when required.
• Afford assistance with protocol implementation and ongoing regulatory maintenance.
• 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.
• Afford assistance 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.