Clinical Research Assistant

1 month ago

Falls Church, United States Virginia Heart Full time

Location: Fairfax

Position type: Full-time /Non-Exempt

$21.00 - $25.00/hr.

The Clinical Research Assistant plays a pivotal role in ensuring the smooth execution of clinical trials conducted at our site. As a vital member of our research team, you will assist in the coordination and management of clinical research studies, ensuring adherence to protocols and regulatory requirements

Roles and Responsibilities:

- Collaborate with the Clinical Research Coordinator to oversee the planning, implementation, and completion of clinical research studies.
- Assist in the recruitment, screening, and enrollment of study participants, ensuring compliance with eligibility criteria.
- Maintain accurate and complete study documentation, including regulatory documents, study protocols, and participant records.
- Coordinate study visits and procedures, including scheduling participant appointments, arranging study-related tests and assessments, and ensuring timely completion of study activities.
- Communicate with study participants, healthcare providers, and other research staff to provide support and ensure study procedures are carried out effectively.
- Assist in the collection, entry, and management of study data, ensuring data integrity and confidentiality.
- Assist in the preparation and submission of regulatory documents to regulatory authorities and institutional review boards (IRBs).
- Participate in study team meetings, training sessions, and quality assurance activities as required.
- Maintain current knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements governing clinical research.

Skill Requirements and Qualifications:

- Bachelor's degree in a relevant field (e.g., life sciences, health sciences, nursing) preferred.
- Prior experience in clinical research or healthcare-related field is advantageous.
- Strong organizational skills and attention to detail.
- Excellent interpersonal and communication skills, with the ability to interact effectively with diverse stakeholders.
- Ability to work independently and collaboratively in a dynamic and fast-paced environment.
- Knowledge of regulatory requirements and guidelines governing clinical research (e.g., ICH-GCP, FDA regulations) is desirable.
- EMR experience, (EPIC a plus) and Microsoft Excel, Word, and Outlook.
- Detailed oriented, excellent written and verbal communication skills.
- Excellent time management skills, team player with the ability to work independently.

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