Job Description

Job Description

Job Description

Summary: The Research Assistant (RA) works with Clinical Research Coordinators (CRC) and other team members and administers research study associated activities, assists in project planning, and ensures that pre-established work scope, study protocol, and regulatory requirements are followed. Additionally, RA recruits and coordinates research subjects, as appropriate, and serves as principle administrative liaison for the project.

Duties and Responsibilities: The Research Assistant:

• Attends Site Initiation Visits (SIV) to prepare for study initiation.
• Assists Clinical Research Coordinators (CRCs) in developing source documentation for capturing data on study protocols.
• Conducts an inventory of study materials and ensures availability for study activities.
• Ensures all study-related training is completed in accordance with sponsor requirements for timely study initiation.
• Inventories protocol shipments, including drugs, laboratory kits, and case report forms (CRFs).
• Maintains supplies for exam rooms and laboratories and ensures cleanliness.
• Assists and/or works in the lab as needed.
• Recruits study subjects appropriate for screening per protocol inclusion/exclusion criteria.
• Ensures study enrollment goals are met as per sponsor requirements.
• Schedules patient visits and prepares source documents for follow-up visits.
• Assists in the completion of informed consent procedures following site SOPs and FDA/GCP guidelines.
• Collects necessary laboratory specimens, EKGs, and subject questionnaires.
• Performs research study visits as assigned.
• Enters information into electronic data capture (EDC) systems.
• Updates study logs, including screening, subject identification, and enrollment logs.
• Updates the research Clinical Trial Management System (CTMS).
• Manages and organizes study files.
• Maintains phone logs for communication with patients and trial sponsors.
• Requests and organizes medical records when needed.
• Prepares and maintains research binders and source documents.
• Assists in preparing documents for submission to the sponsor and Institutional Review Board (IRB).
• Prepares lab shipments and ensures timely transportation to couriers.
• Transports laboratory tubes and medications between the office and other site units.
• Performs and documents vital assessments of patients.
• Communicates with the central lab regarding abnormal lab values and notifies the manager of any significant findings.
• Completes all study-specific training as assigned by sponsors or management.
• Participates in site meetings and contributes relevant input.
• Provides assistance and training to new and current staff members.
• Collaborates with the Site Director, CRCs, and other team members to ensure smooth study operations.
• Ensures confidentiality of participants’ health information and study-related data.
• Occasional travel to company sites, investigator meetings, and/or company meetings.
• Performs other job-related duties as assigned by the manager, CRCs, or other management team members.
• Occasional travel to Company sites, Investigator meetings, and/or Company meetings.
• Performs other miscellaneous job-related duties as assigned by your manager, Clinical Research Coordinators, or other management members.

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:

• High School Diploma required.
• And 1-5 years of on-the-job training as a Research Assistant

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.

Competency Requirements:

• Excellent communication skills
• Problem Solving skills.
• Planning /Organizational Skills
• Personal Motivation
• Customer Service Skills
• Understanding of ICH/GCP guidelines for human research
• Understanding of Code of Federal Regulations for Human Subject
• Computer Competency in Electronic Data Capture
• Phlebotomy skills and other technical skills related to completion of study visits as required by the protocol.

Physical Requirements:

• Laboratory Processing Procedures.
• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift 20 pounds at times.
• Exposure to human bodily fluids.
• Occasional weekend schedules.

Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.

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