The Clinical Research Coordinator is primarily responsible for identifying and promoting the enrollment of all protocol eligible patients for assigned clinical studies. The Coordinator is also responsible for assuring compliance with study protocols, data documentation, reporting requirements, and correspondence with the institutional review board (IRB) as well as the Cancer Center.
Job Responsibilities include but are not limited to:
- Serve as primary contact with research participants, sponsors, and regulatory agencies.
- Coordinate studies from start-up through close-out.
- Reviews and develops a familiarity with protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Determine eligibility of and gather consent materials from study participants according to protocol. Assist in developing recruitment strategies.
- Registers new patients onto studies in a timely manner. Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- Collaborates with all study sites and aids institutions in data collection, and submission of on-going documents and specimens.
- Spins, separates and prepares specimens when needed; sends requested specimens in timely manner. Collects and submits tumor tissue samples and pathology slides as required.
- Provides in-service education and on-going communication to CRA peers and collaborating institutions with study updates.
- Reviews medical records; transcribes relevant information from record onto the appropriate flow sheets or electronic data base.
- Enters and tracks all patient data into appropriate data collection systems
- Completes study documentation and maintains study files in accordance with requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
- Monitors website for protocol updates and reports all protocol modifications, amendments, and renewals to NCI, the IRB, and Cancer Center
- Prepares all materials for both institutional and cooperative group audits.
- Performs other related duties as required.
Minimum Qualifications and Experience:
- Bachelors degree preferred, 2 years equivalent experience acceptable
- Excellent organization, computer literacy and communication skills
- Knowledge of medical terminology
- Spanish fluency a plus
Recommended Knowledge, Skills, and Abilities:
- Knowledge of the principles of clinical research and federal regulations.
- Familiarity with IRB guidelines and regulations.
- Previous experience with clinical trials.
- Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
For additional information or to express interest please contact Dara Steinberg, Ph.D. at dms2207@cumc.columbia.edu. If interested in the position, please include a Cover Letter and CV.
