Clinical Research Assistant (Full-Time, On-Site)

The Clinical Research Assistant will provide support to the Clinical Research Coordinator, Regulatory Coordinator and administrative staff of the Clinical Research Department.

Job Relationships

• Reports to the Clinical Research Manager

Principal Responsibilities

• Provide support to office operations
• Collaborate within multi-disciplinary team settings
• Gather and prepare study-related materials for participants visits
• Schedule patients for research appointments
• Assist with study investigational product receipt and tracking
• Maintain proper documentation study-specific documentation and guidelines
• Collect, process and ship biologic specimens
• Administer structured tests and questionnaires according to research study protocols
• Utilize study-related technology and equipment as part of data collection procedures
• Uses discretion to resolve issues when unplanned events arise
• Assist with regulatory coordinator on overseeing details of clinical studies and ensure compliance with study review board and clinical research regulations
• Assist with other duties as assigned by research team
• Comply with the Springfield Clinic incident reporting policy and procedures
• Provide excellent customer service and adhere to SC Code of Conduct and Ethics Standards
• Perform other job duties as assigned

Education/Experience

• Bachelor's degree is preferred but will consider relative experience
• Clinical Research experience strongly preferred

Licenses/Certifications

• CPR certification per American Heart Association guidelines required within 30 days of hire
• IATA training within 30 days of hire
• GCP training within 30 days of hire

Knowledge, Skills and Abilities

• A strong working knowledge of computer software including Microsoft Office, Electronic Medical Record(s), other SC platforms, and Sponsor required systems.
• Attention to detail and ability to follow and interpret approved clinical protocols is required.
• A strong working knowledge of GCP, ICH, CFR, and HIPAA laws and regulations will be required.
• Knowledge of Springfield Clinic policies and procedures.
• Ability to demonstrate good organizational skills, excellent oral & written communication skills, and excellent interpersonal skills in working effectively with Co-workers; Managers; Directors; Administration; Providers; Staff; Sponsors and Patients.
• Ability to recognize, evaluate and solve problems.
• Ability to manage projects in a team environment.
• Ability to function and perform daily work independently; perform duties and tasks assigned and follow through to completion.
• Must have the ability to maintain composure under stress, using tact and good judgment.
• Must be able to stand and walk for long periods and capable of stooping, bending, and lifting.

Working Environment

• Office based with travel to other Springfield Clinic locations (including satellite offices) and other business-related travel, as required to conduct day to day business aspects of the department.

PHI/Privacy Level

HIPAA1