Clinical Research Coordinator – Must have at least 2 years clinical trials experience

Job Responsibilities:

• Additional responsibilities as needed including: Help in the development of SOPs, policy changes, education sessions, and quality improvement projects
• Work with licensed clinicians to develop tracking forms for all active trials, maintain tracking forms throughout the life cycle of the protocol
• Provide updates to study team members regarding changes to workflow or patient-related specific needs according to protocol modifications
• Schedule participants according to the approved protocol; coordinate with ancillary service providers to ensure patients remain adherent to the protocol
• Prepare for study visits: bio-specimen collection, research ticket preparation, lab and EKG orders, scheduling of biopsies and scans, facilitating, AE and Conmed form completion in conjunction with licensed professional and other tasks as needed.
• Act as primary point of contact for all bio-specimen collections
• Maintain follow up calendar ensuring all survival follow up assessments are completed per the protocol; performs assessments not requiring licensure
• Participates in Pre-Screening activities to identify patients that may be eligible for a clinical trial
• Participates in the feasibility and complexity assessment process for new protocols
• Assists patients in understanding the schedule of assessments according to the approved protocol, coordination of appointments, and ancillary services (under the supervision of a licensed clinician but clinician does not have to be physically present)
• Under the supervision of investigator, may take part in AE and Con Med documentation and reporting activities such as SAE and ECI reports (All documentation must be verified and signed by licensed clinicians before submission and all assessments must be made by a licensed clinician)
• Write research notes in EPIC (may not make assessments)
• Helps compile enrollment packet materials (must be reviewed and signed by investigator)
• Human Subjects’ Research – As applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials and any other appropriate parties in order to obtain approval to conduct human subjects research (e.g., ensures the update and submission of necessary documents and/or forms to appropriate destination). Might prepare, audit and submit monthly enrollment statistics to the Office of Clinical Trials, and provides other information in timely manner, as necessary.
• Budget – Develops a preliminary draft budget and submit to the Director/Principal Investigator. Reviews sponsor-proposed budget for adequate coverage and recommend changes as appropriate. Assists in the preparation of funding reports to funding agencies and helps identify new potential sponsors/agents for trials and researches. Monitor budget throughout trial.
• Data Management – Responsible for collecting and auditing patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc); abstraction of data for publications, or data collection from outside physicians offices. Audits and manages data from and into the database. Prepares forms and reports, compiles and analyses data, statistics, and other materials for reports. Conducts study visits, obtains and documents information within the time frame specified.
• Grants – Prepares and submit grant applications and other grants related an activity such as developing grants applications/proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if applicable. Follow up and coordinates resolution of all issues progress. Reports to the sponsors to fund medical research in the division.