Job DescriptionA Senior Clinical Research Coordinator position is available 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, analyzes and interprets highly complex clinical research data; conducts clinical testing and develops 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. Assists with protocol submissions, database enhancements, and budget preparation.
Responsibilities- Participate in Clinical Trial Feasibility, Site Selection Process and Site Initiation Visit.
- Portfolio will include but not limited to complex, first-in-human Phase 1 and Phase 2 trials.
- 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 including RTC, and inpatient floors.
- Pre-Screen patients by conducting Medical Records review.
- With input from Pis and Research RNs, create and maintain Standard Operating Procedures (SOPs) specific for each study.
- Coordinate the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects.
- Prompt Pls, Research Team including Research RNs 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.
- Track and maintain Investigator New Drug Safety Reports and identify trends in adverse events.
- Assist in preparing and ensuring that grant applications and IRB/GCO documents are submitted.
- Coordinates protocols and human subject approvals between various sites.
- Assist the Principal Investigator 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 CRC I and CRC II and CRC at other sites for multi-center trials.
- Develops work flow policies and procedures for assigned trials.
- Prepares reports for presentation in conferences and seminars.
- Oversees data collection, processing, storage, inventory and quality control for clinical research studies.
- Assists in budget preparation and negotiation and assure research billing compliance.
- Prepare and participate in external audits including FDA audits.
- Perform other duties assigned.
Qualifications- Bachelors degree in sciences or related field. Masters degree preferred
- 5 years of clinical research
- Preferred:
- Excellent written and oral communication skills
- Exceptional attention to detail and accuracy
- Ability to manage multiple tasks & priorities
- Demonstrated leadership potential
