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CRA x 2

Website Achieva Group Limited

An excellent opportunity has arisen to join a leading pharmaceutical company as a CRA – IVD x 2.

The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

The perfect candidate has a degree in Medical technology with first professional experiences in clinical research or laboratory research.
Additionally, the person brings basic knowledge of, and skill in applying, applicable clinical research regulatory requirements as well as excellent oral and written communication skills in English.

Tasks & Responsibilities:
• Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements
• Validating product performance claims
• Supplying data for critical Regulatory submissions
• Defining the functional and clinical utility of investigational products
• Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders
• The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions
• Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout
• Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met
• Interfacing with cross functional staff to support post launch activities
• Reviewing cases with investigators to resolve discrepancies
• Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and policies and procedures

Must Haves:
• Bachelor’s degree in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate (*****)
• Preferably experience in clinical research or laboratory research (*****)
• Min. 2 years of prior relevant experience (*****)
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines) (*****)
• Excellent oral and written communication skills in English
• Excellent planning, organizing, and interpersonal skills
• Ability to work independently, make sound decisions, and to analyze and solve problems
• Medical laboratory experience preferred
• Good therapeutic and protocol knowledge.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
• Organizational and problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients

Nice to Have:
• Experience in Pathology

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