Regional CRA

Regional CRA- United States

Contract Length: 6 mos

Number of Openings: 2

Job Description:

• Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
• Ensures validity of study by identifying/resolving discrepancies and obtaining missing data and may track core lab activities and more complex components of the trial.
• Contributes to developing and writing clinical protocols, case report forms, and other study aids for investigational products by addressing issues by interacting with appropriate personnel.
• Maintains expertise in regulations for applicable geographies and types of studies (IDE, non­ significant risk, feasibility, exempt, etc.). Serves as a resource related to clinical trial regulations.
• May mentor and train new employees.
• Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support
• Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures and regulations.
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Other miscellaneous duties as may be required.

Accountability/Scope/Budget

• Excellent Communications skills, both oral and written.
• Ability to initiate, plan and manage projects.
• Strong decision-making skills and ability to prioritize.
• Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.

Knowledge:

• International Harmonized /Committee Good Clinical Practices, IHC/GCP.
• Current Good Manufacturing Practice 21 CFR Part 820 is an asset.
• Knowledge of project management tools and techniques.
• Broad knowledge and application of business concepts, procedures and practices.
• Advanced English Oral/Written.

• Bachelor's degree or equivalent experience required; prefer background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology, Respiratory Therapy or related field of study).
• Require 3-6 years on-site monitoring experience
• Travel up to 30% of the time domestically and / or internationally may be required.