Clinical Research Associate - Clinical Research - Bethesda, MD | Biospace
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Clinical Research Associate - Clinical Research

Technical Resources International Inc.

Location:
Bethesda, MD
Posted Date:
8/24/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Clinical Research, CRA,

Job Description


Founded in 1979, Technical Resources International, Inc. (TRI) provides a unique range of support services in the areas of Communications, Health and Information Technology to both private industry and government agency clients.  TRI is currently seeking a Clinical Research Associate to join our Bethesda, MD team.

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.
•   Assist in protocol, Informed Consent, and CRF design and review.
•   Develops 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.
•   Decisions are made independently and with some supervision from Director, Clinical Operations/Project Management or Project Manager.
•   Tasks are primarily intellectual and require exercise of discretion and independent judgment.

Requirements


Requirements

•   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.
•   BS/MS/RN or equivalent in scientific or health care field; CRC experience a plus.
•   Four years of pharmaceutical, clinical, or biological research experience with 2–3 years of CRA experience

Submit resume and salary requirements to:  Attn: NN, TRI, 6500 Rock Spring Drive, Suite 650, Bethesda, MD 20817, or fax to (301) 897-1702, or click Apply Now to submit.

Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.