Job Abstract

Come join our team!

The Research Support Assistant provides clerical support to Clinical Research Associate, Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Research Manager. This role will provide the administrative support for research protocols by providing document management, obtaining proper signatures, and maintaining samples, kits, and study supplies. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.

Primary Duties and Responsibilities

• Completes data entry and manages documents for research activities and provides clerical support to the department.
• Handles the process of obtaining the proper signatures for research grants and protocols.
• Provides administrative support for research protocols.
• Completes sample preparation and shipping and maintains study supplies and kits.
• Responsible for obtaining outside research records for patients enrolled in protocols.
• Schedules research meetings.
• Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
• Maintains research practices using Good Clinical Practice (GCP) guidelines.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
• Participates in required training and education programs.

Department-Specific Responsibilities

• Under the supervision of the department chair, medical/nursing directors, and research leadership, integrates and is actively involved in specified processes to gain direct understanding of quality improvement opportunities. Functions may include supervised contact with patients and research participants to collect quality improvement data and facilitate department research activities.
• Prepares and submits protocols and supporting documents to regulatory bodies such as the Institutional Review Board (IRB).
• Collects, audits, tracks, and analyzes health care data and maintains clinical databases for quality improvement purposes.
• Works with interdisciplinary team members to develop and standardize reports, questionnaires, and participates in comparative studies, data analysis, and interpretation.
• Collects, processes, and prepares specimens and transports to lab. Follows hospital policy for specimen labeling, logging, and storage.
• Provides supervised contact with patients for quality improvement purposes or with research participants for IRB-regulated clinical research protocols, such as interviewing patients, collecting data, taking vital signs, performing EKG's, and other non-invasive clinical or research activities.
• May draft reports, manuscripts, and other deliverables for internal or external presentation or publication. Performs other duties as assigned.

Education Requirements:

• High School graduate or equivalent required.

Experience Requirements:

• No experience required.
• Previous coursework and experience in related field preferred.

Licenses & Certification Requirements:

• No license & certification required.
• Certified Nursing Assistant (CNA), CA Phlebotomy Certification, or Emergency Medical Technician preferred.

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