Clinical Research Assistant

NextStage Clinical Research is seeking an experienced Clinical Research Coordinator, who is self-motivated, driven and works well with others in a collaborative environment to join our team in the Sydney, including zip codes: NextStage Clinical Research is a fast growing, integrated site management research organization that is partnering with prominent private practice physician groups to deliver innovative healthcare solutions to more patients. NextStage is poised for accelerated business growth through our experienced team of highly skilled and trained clinical professionals, best in class physicians partners and thought leading leadership team.

**Key Job Details**:Competitive compensation & benefits package.Full-time opportunity with core days/hours M-F 8AM-5PM, and with flexibility to work remotely and in the office. 15% occasional travel nationwide.

**Job Summary**:
The Clinical Research Assistant will coordinate the execution of all clinical study protocol activities while maintaining Good Clinical Practice (GCP) and adhering to the Food and Drug Administration (FDA) regulations. The main responsibility is the conduct of multiple clinical trials, working closely with the Principal Investigator, Sub-Investigators, and Clinical Coordinator.

**Essential Duties & Responsibilities**:

- Interprets protocol(s) correctly and completely to ensure consistent compliance with applicable standards and related requirements.
- Educates patients and healthcare professionals on the study protocol to ensure complete and correct understanding of information.
- Presents information and responds to questions in accordance with standards of professional practice and compliance requirements in relation to matters including, but not limited to, obtaining informed consent.
- Maintains clinical source records.
- Organizes Investigator Site Files.
- Ensures call notes and documentation is accurate.
- Complies with all regulatory requirements, guidelines, and local regulations.
- Prepares IRB submissions to include but not limited to development of ICF and any supporting documentation required for submission.
- Prepares Regulatory documents per sponsor requirements (FDA Form 1572, Financial Disclosure forms, etc.).
- Coordinates and maintains the following logs: Delegation of Authority, Deviation Logs, Enrollment, Study Status Logs.
- Transcribes source to EDC platforms.
- Hosts Sponsor and Monitor Visits.
- Demonstrates integrity, teamwork, respect, and accountability in all aspects of the job.
- Performs job duties and assigned tasks in a safe, efficient, and effective manner, as well as in a manner that is compliant with all company policies, procedures, protocols, and practices.
- Perform other duties assigned as it relates to the business needs

Minimal Education & Experience Requirements:

- High school diploma or equivalent GED
- Clinical Research Coordinator with Phase 1 and outpatient trials experience
- 1 to 3 years of experience working in Clinical Assistant role; or
- An equivalent combination of education and experience
- Must be able to provide guidance to research naïve staff
- Knowledge of protocol and medical terminology
- Knowledge of regulatory requirements and HIPAA requirements
- Strong team player with interpersonal skills
- Must be able to work in a high pace environment
- Exceptional organizational and time management skills, ability to prioritize task - Detailed oriented
- Computer Skills (familiar with electronic health record systems, Microsoft Office
- Certification preferred, GCP and IATA

Physical Requirements & Working Environment:
This position requires frequent sitting, walking, standing, reading, seeing, speaking, hearing, listening, organizing, interpreting data and information, operating office equipment, typing using a computer keyboard, and viewing a computer screen monitor. The working environment consists of an indoor and climate-controlled setting the majority of the time, and with frequent exposure to a healthcare clinical setting to include, without limitation, frequent potential exposure to blood borne pathogens, and other possible hazards within a clinical setting.

Equal Opportunity Employer

**Salary**: $50,000.00 - $75,000.00 per year

Schedule:

- 8 hour shift

Supplementary Pay:

- Tips

Ability to commute/relocate:

- Randwick NSW: Reliably commute or planning to relocate before starting work (preferred)

**Education**:

- Bachelor Degree (preferred)

**Experience**:

- Clinical research: 1 year (required)

Work Authorisation:

- Australia (required)