Research Study Assistant

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Research Study Assistant position will provide general research and administrative support to clinical trials conducted through the Clinical Protocol & Data Management Office. This position reports directly to the Clinical Research Manager of the specific disease site this incumbent is assigned to.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process. This position is primarily based out of 161 Fort Washington Avenue, New York, NY.

Responsibilities

The Research Study Assistant (RSA) assists in the coordination of visits and works with the study team to maximize work efficiency to gather all required data and relevant clinical information.

Responsibilities include, but are not limited to :

GENERAL STUDY MANAGEMENT

• Reviewing research protocols and understanding study requirements.
• Performs all duties maintaining HIPAA and GCP standards
• Under the supervision of the clinical research manager, the RSA maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings. The coordinator will also comply with the necessary regulatory responsibilities as needed.
• Utilize work logs, attend regular meetings, and meet regulatory responsibilities as required.

PATIENT MANAGEMENT

• Collaborate with Clinical Research Coordinators, Clinical Research Nurses, and Investigators to :
• Schedule assessments and appointments per protocol or as instructed.
• Prepare kits, scan documents (e.g., visit packets) into the Electronic Medical Record (EMR), redact documents, and obtain signatures.
• Manage drug returns to the Research Pharmacy.
• Collaborate with Clinical Research Coordinators, Clinical Research Nurses, and Investigators to :
• Communicate with various departments, physicians, labs, outside hospitals, and the clinical team to ensure timely and accurate data retrieval.

DATA MANAGEMENT

• In conjunction with Data Coordinator, assembles, organizes, and enters clinical research data as needed.
• Assists in maintaining and updating sponsor-related, university and department databases / logs.

OTHER

• Deliver correlative specimens to the lab for processing as required
• Ships correlative specimens to external Sponsors as outlined in the laboratory manual.
• RSA performs other related duties and participates in special projects as assigned.
• Take on other tasks as needed to support the research team.

Minimum Qualifications

• High school diploma.

Preferred Qualifications

• Strongly prefer Associate's degree or equivalent in education and experience.
• Experience in clinical research setting with knowledge of HIPAA and GCP.
• Excellent interpersonal and organizational skills.
• Computer Skills : proficiency with MS programs (Word, Excel, etc.) and familiarity with Mac and PC platforms.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.