Administrative Skills, Clinical Research, Clinical Support, Clinical Trial, Contract Research Organization (CRO), Depth Perception, Document Archiving, Documentation, Documentation Review, Drug Development, GCP (Good Clinical Practices), Hematology, ICH Regulations, Logistics, Mail Processing, Oncology, Operational Support, Pagination, Physical Demands, Project Execution, Project Planning, Project Tracking, Regulations, Standard Operating Procedures (SOP), Status Reports
POSITION SUMMARY:
This opportunity will support the Clinical Operations team in a fast paced, busy hematology/oncology pharmaceutical development department. As a Clinical Trial Assistant (CTA), you will assist the clinical research teams in clinical trial conduct, oversight, and logistics by providing administration and project tracking support.
Salary Range: Premium (NY/CA) $78,000 to $95,000
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide administrative support to the Clinical Operations Department.
- Assist Clinical Operations in minute generation and finalization of study related meetings. .
- Support the Clinical Operations teams with archived, ongoing, and future clinical conduct of studies.
- Be familiar with ICH, GCP, appropriate regulations, Rigel SOPs and internal systems.
- Assist internal and external project teams with documentation and guidelines as appropriate.
- Maintains and manages the study trial master files using Veeva Vault and other platforms.
- Organize study documentation, including archiving, reviewing, and standardizing local study files for department consistency.
- Accurately uploading and filing study documents to the Veeva Vault electronic Trial Master File.
- Ensures study documents filed into the Veeva Vault electronic Trial Master File comply with filing guidelines and acceptability criteria. This includes, but is not limited to, reviewing documents for accuracy, quality and legibility, pagination, layout orientation, filing location, and compliance with GCP guidelines.
- Provides additional support in quality reviews of study the trial master file plans and indexes.
- Route and manage correspondence for the clinical trial teams.
- Provides administrative support with department project planning, execution, and follow up.
- Assist with team member tracking and distribution of study related information.
- Tracking of screening, enrollment, and subject status reports from CRO and sites.
KNOWLEDGE AND SKILL REQUIREMENTS:
- Bachelor’s degree in science related field required. 1-2 years’ experience in clinical research type role preferred.
WORKING CONDITIONS:
- PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
- WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required.
Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
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Rigel Pharmaceuticals, Inc.