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Dept- Tisch 015 REQ # 2653536
Job Title: Sr. Clinical Research Coordinator
A Senior Clinical Research Coordinator position is available in the Cancer Clinical Trials Office (CCTO) within the Tisch Cancer Institute. The Senior Clinical Research Coordinator will work with Principle Investigators (PIs), Research Manager and Clinical Research Team to manage data associated with cancer clinical research protocols.
Under general supervision, duties include: analyzing and interpreting highly complex clinical research data; conducting clinical testing and developing protocols; develops work flow policies and procedures; mentors, trains and reviews the work of less experienced clinical research staff; oversees the clinical assessments of the study subjects; and assists with protocol submissions, database enhancements, and budget preparation.
The Tisch Cancer Institute is a vital component of the Icahn School of Medicine at Mount Sinai Hospital and plays a key role in the Mount Sinai Health System, which is one of the largest health care systems in the nation. We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer. Our Cancer Clinical Trials Office (CCTO) provides the infrastructure and resources required to support patient-based cancer research.
- Manage a complex clinical trial portfolio which may include, but is not limited to, first-in-human Phase 1 and Phase 2 trials.
- Participate in Clinical Trial Feasibility, Site Selection Process and Site Initiation Visit as required.
- Pre-Screen patients by conducting Medical Records review.
- Coordinate the clinical assessments of the study subjects, including but not limited to, screening and evaluation of the study subjects.
- Coordinate patient care with ancillary department (such as pathology, interventional radiology, immune monitoring core, clinical laboratory, surgery, stem cell lab, transplant team and clinical services within the Ruttenberg Treatment Clinic (RTC)) per protocol requirements.
- With input from the Principle Investigators (PIs) and Research Nurses; create and maintain Standard Operating Procedures (SOPs) specific for each study.
- Prompt the Principle Investigator(s), and other research team members, about protocol requirements for upcoming study visits.
- Collect required data and maintain the data management database.
- Design specific projects data sets, including the selection of appropriate methods and techniques to capture in Case Report Forms (CRFs).
- Track and maintain Investigator New Drug Safety Reports and identify trends in adverse events.
- Assist the Principal Investigator (PI) and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
- Mentors, trains and reviews the work of less experienced clinical research staff; may oversee CRCs at other sites for multi-center trials.
- Develops work flow policies and procedures for assigned trials.
- May prepares reports for presentation in conferences and seminars.
- Oversees data collection, processing, storage, inventory and quality control for clinical research studies.
- Prepare and participate in audits as required.
- Perform other duties as assigned.
- Bachelor's degree in health related field; Master's degree preferred.
- 5 years of clinical research experience; oncology experience preferred
- Excellent written and oral communication skills
- Exceptional attention to detail and accuracy
- Ability to manage multiple tasks & priorities
- Demonstrated leadership potential