
Springfield Clinic, LLP
Description
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