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

Technical Resources International Inc.

Location:
Bethesda, MD
Posted Date:
8/11/2017
Position Type:
Full time
Job Code:
CRA
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biology Research, Clinical Research, Clinical Trial,

Job Description

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