CLINICAL RESEARCH ASSOCIATE I
Job Posting for CLINICAL RESEARCH ASSOCIATE I at Technical Resources International, Inc.
Location
Bethesda, MD 20817 US (Primary)
Category
Clinical Operations
Job Type
Full-Time
Education
Bachelor's Degree
Travel
Up to 50%
Job Description
- Provides site management and monitoring support for sponsored clinical studies; primarily Phase I and II, with limited Phase III and IV.
- Performs on-site pre-study/qualification, initiation, routine, and close-out visits. Prepare site visit reports and provide assistance to site staff in resolving deficiencies.
- Educates and trains site and study staff in management of sponsored studies, including assurance to regulatory and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) compliance.
- Collects and processes regulatory documentation for investigational studies in compliance with required guidelines. May review essential regulatory documents for content and accuracy.
- Assist in protocol, Informed Consent, and CRF design and review.
- Develop and demonstrate understanding of and apply therapeutic area knowledge to assignments and project-related issues.
- Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager or Clinical Trial Manager.
- Decisions are made independently and with some supervision from Project Manager or Clinical Trial Manager.
- Tasks are primarily intellectual and require exercise of discretion and independent judgment.
Job Requirements
- Four years of pharmaceutical, clinical, or biological research experience with at least 2 years of CRA experience
- Working knowledge of SOPs along with Food and Drug Administration and ICH/GCP guidelines.
- Good communication, organizational, and writing skills.
- Develops and applies efficient computer tools to carry out job functions.
- Attention to detail, ability to work in a team environment.
- Dependable, assumes responsibility and accepts, supports, and positively facilitates change.
- Ability and availability to communicate with sites in different US time zones.
- Has the ability to travel (on avg. 50% of time), including international travel.
We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.
Salary.com Estimation for CLINICAL RESEARCH ASSOCIATE I in Bethesda, MD
$74,434 to $99,488
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Job openings at Technical Resources International, Inc.
Technical Resources International, Inc.
Bethesda, MD
Full Time
Technical Resources International, Inc.
Bethesda, MD
Full Time
Technical Resources International, Inc.
Bethesda, MD
Full Time
Technical Resources International, Inc.
Bethesda, MD
Full Time
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