Category: Scientific & Clinical
Regional CRA- United States
Contract Length: 6 mos
Number of Openings: 2
- 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.
- 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.
- 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.