Clinical Research Coordinator II - Tisch Cancer Center

Responsibilities

• Coordinates activities of ongoing clinical trials
• Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
• Obtain informed consent under supervision of the study investigator(s); educate participants regarding study requirements.
• Screen patients for eligibility and register subjects with sponsoring agency.
• Coincide research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing.
• Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol.
• Act as liaison between investigator(s) and sponsoring agency.
• Coordinate activities pertinent to the safeguarding of patients’ rights in research.
• Manage study data of ongoing clinical trials under supervision of the Principle Investigator(s).
• Ensure accurate and complete compilation of subject data through chart reviews.
• Collect and record study data on Case Report Forms (CRFs) and submit forms in a timely manner according to study guidelines.
• Meet with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol.
• Maintain source documents and subject files in accordance with Mount Sinai School of Medicine (MSSM) Standard Operating Procedures (SOPs).
• Aid in analyzing data as needed.
• Ensure proper compliance with institutional and national regulatory requirements.
• Report adverse events and serious adverse events in accordance with MSSM Institutional Review Board (IRB) SOPs, sponsor guidelines, and federal regulations.
• Aid in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.
• Perform other job related duties as required, which may include but not limited to:
• Participate in Investigators’ Meetings and assist with coordinating Study Initiation Visits.
• Attend divisional/departmental/institutional educational and training seminars.
• Contact local physicians to obtain source documentation and subject survival status.
• Educate new staff regarding overview of clinical research, office policy and procedures, data submission, patient registration and specimen handling.

  Qualifications

  • Bachelor's degree in sciences or related field.
  • 2 years of clinical research.
  • PREFERRED: Working knowledge Good Clinical Practice guidelines and Federal research regulations.
  • Demonstrate strong organizational and communication skills.
  • Oncology experience preferred.
  • Must be comfortable communicating clinical information to medical personnel.
  • Strong computer literacy required.