Job Description

Job Description

Job Description

Summary: The Research Assistant works with Study Coordinators and administers research study associated activities. Assists in project planning, and ensures that pre-established work scope, study protocol, and regulatory requirements are followed. Recruits and coordinates research subjects, as appropriate, and serves as principle administrative liaison for the project. Maintains recordkeeping systems and procedures and source documentation. Performs patient care as directed by Principal Investigator and study protocol.

Responsibilities:

• Complies with Company handbooks, policies, and procedures;
• Participates in site meetings and provides input;
• Assists the Site Lead, Clinical Research Coordinators, and other Research Assistants in organizing and maintaining the site, which may involve administrative functions including but not limited to:

• entering information in EDC systems (electronic data capture)
• inventory of research and lab supplies
• maintains lab logs, IP logs, and Transportation logs as needed
• Orders lab kits/supplies
• answering incoming calls
• calling study subjects when necessary
• maintaining a clean office and lab environment
• maintaining and organizing study files
• requesting medical records when needed
• data entry as assigned

• Inventories protocol shipments, such as drugs, labs, CRFs;
• Assists and/or works in the lab as needed;
• Completes study-specific trainings as assigned by sponsors;
• Maintains phone logs of communications with patients and trial sponsors;
• Updates study logs, including screening, subject identification, and enrollment logs;
• Prepares research binders;
• Obtains signatures from Principal Investigator(s) and Sub-Investigator(s), as needed;
• Updates the research CTMS as needed;
• Prepares source documents, records, and algorithms;
• Assists in preparing documents for submission to the sponsor and IRB;
• Obtains blood and other specimens as necessary;
• Picks up lab samples and transports back to lab;
• Processes lab specimens and prepares lab shipments;
• Transports lab tubes and medications from the office to other site units;
• Performs vital assessments of patients and document on designated logs;
• Ensures confidentiality of subjects’ health information;
• Maintains confidentiality of all study and protocol information;
• Notifies Manager of abnormal laboratory values or clinical observations;
• Communicates with central lab regarding abnormal lab values;
• Performs research study visits as assigned;
• Maintains adequate documentation on patient source documents, the Company’s CTMS system, and via e-mail;
• Provides assistance and training to new and current staff members when necessary;
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings;
• Performs other duties as assigned by your Manager, Clinical Research Coordinators, or any other member of Management

This job description is not an exhaustive list of all the functions that you may be required to perform. The Company reserves the right to revise this job description at any time.

Requirements:

• Knowledge of medical terminology
• Understanding the principles of administration and management

Education:

• High School Diploma
• Or a degree in nursing or health related field
• And 1-5 years of on-the-job training as a clinical research assistant or research study coordinator

Continuing Education:

• IATA (dangerous goods handling)
• GCP (good clinical practice)
• BLS/Phlebotomist course, if required by your Manager
• CPR course, as arranged from time to time by the Company on-site
• Stericycle Trainings, first week of your hire date
• Maintain evidence of completion of all continuing education

Physical Requirements and/or environmental factors:

• Prolonged periods of sitting at a desk and working on a computer
• Prolonged periods of standing and walking around the office
• Must be able to lift 20 pounds at times
• Travel to sponsor required meetings as needed
• Exposure to human bodily fluids
• Occasional night and weekend work schedules
• Overtime may be required at times
• Work is normally performed in a typical interior clinical/office environment

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