Research Study Assistant

Columbia University in the City of New York; New York (NY); On-site; USD 48,000 - 49,000; Full time

Job summary

Columbia University Irving Medical Center (CUIMC) seeks a Research Study Assistant to support clinical trials in the Department of Surgery. The RSA will provide general research and administrative help, ensuring data integrity and regulatory compliance.

Under the Director of Clinical Research Operations, you will assist with data entry, scheduling, specimen handling, and regulatory responsibilities to support trial activities at CUIMC.

Qualifications

• Bachelor's degree or equivalent in education, training and experience.
• Strong proficiency in Microsoft Office, especially Excel.
• Bi-lingual (Spanish and English) preferred.
• Experience in clinical research with HIPAA and GCP knowledge.

Responsibilities

• Review protocols and study requirements.
• Maintain HIPAA and GCP standards.
• Maintain data management procedures under supervision and use work logs/regulatory tools.
• Collect, process, and ship specimens as required.
• Schedule assessments and appointments per protocol.
• Prepare kits and document scans into the EMR; obtain signatures.
• Coordinate with departments and clinical team for timely data retrieval.

Skills

Microsoft Office

Excel

Education

Bachelor's degree or equivalent in education, training and experience

Job description

• Job Type: Support Staff - Non-Union
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule: Mon - Fri (9am - 5pm)
• Building: Columbia University Medical Center
• Salary Range: $48,000.00 - $49,000.00

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

Columbia University Irving Medical Center (CUIMC) provides global leadership in scientific research, health and medical education, and patient care. Working in the Department of Surgery in the Transplant Clinical Research Center (TCRC), under the direction of the Director of Clinical Research Operations, the Research Study Assistant (RSA) will provide general research and administrative support to clinical trials managed by the Department/Division.

Responsibilities

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 are required.
• Collect, process, and ship specimens as required.

Patient Management:

• Schedule assessments and appointments per protocol or as instructed.
• Prepare kits, scan documents into the Electronic Medical Record, redact documents, and obtain signatures.
• Manage drug pickups and returns to the Research Pharmacy.
• Administer noninvasive research tests, such as questionnaires and surveys.
• Communicate with various departments, physicians, labs, outside entities, 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.
• Perform other related duties and responsibilities as assigned/requested.

Minimum Qualifications

• Bachelor's degree or equivalent in education,trainingand experience.
• Working knowledge of Microsoft Office, including strong Excel skills.

Preferred Qualifications

• Bi-lingual (Spanish and English).
• 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.

Other Requirements

• Work requires manual dexterity for handling charts and using office equipment - specifically the use of a computer keyboard and calculator. Must be able to stoop and bend to retrieve files and supplies, and sit, stand or move around for extended periods of time.

Equal Opportunity Employer / Disability / Veteran

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