Job Description
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We are seeking a skilled Clinical Research Associate II to join our team. As a Clinical Research Associate, you will play a crucial role in ensuring the success of our clinical trials by coordinating and conducting site visits, managing documentation, and leading procedures.
Responsibilities include:
* Conducting remote or on-site visits to assess protocol and regulatory compliance
* Managing required documentation and ensuring audit readiness
* Developing collaborative relationships with investigational sites and client company personnel
Requirements:
Education and Qualifications
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification.
Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials may be considered.
Valid driver's license where applicable.
Key Skills and Abilities
Ability to attain and maintain a solid understanding of ICH GCPs and applicable regulations and procedural documents
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Ability to maintain customer focus through the utilization of good listening skills and attention to detail
Good organizational and time management skills
Ability to remain flexible and adaptable in a wide range of scenarios
Well-developed critical thinking skills and problem solving
Ability to manage Risk Based Monitoring concepts and processes
Benefits
Our organization offers a comprehensive benefits package, including health and wellbeing programs, flexible arrangements, generous leave policies, paid volunteer time, and opportunities for learning and development.
As a valued member of our team, you will have access to a range of benefits that support your physical, mental, and financial wellbeing.
Work Environment
This role requires independent travel up to 80%, inclusive of traveling in automobiles, airplanes, and trains.
As a condition of employment, you must have received your Covid-19 vaccine and disclose proof of your vaccination status upon employment.