Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
A Clinical Research Associate (CRA) is responsible for conducting monitoring activities at a clinical site(s) for a clinical trial(s).The CRA may be responsible for multiple projects and must be able to work both independently and in a team environment.
The CRA will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct.
The CRA will ensure subject safety and verify diligence in protecting the confidentiality of each subject.
The CRA shall guarantee the adequacy, the reliability and quality of the data collected from sites and shall participate in the quality control processes.
The CRA will make sure that the conduct of the study is in compliance with the currently approved protocol/amendment(s), with ICH GCP, SOPs and with any applicable regulatory requirements in the assigned countries.
The CRA will have to anticipate, recognize and resolve issues in the served study sites.
- Follow Standard Operating Procedures (SOPs)
- The CRA will be assigned clinical monitoring activities in a single country or in several countries ensuring quality service and appropriate clinical study conduct
- Preparation and/or review of any kind of study documents, Monitoring Guidelines , CRF Completion Guidelines, Patient Information and Informed Consent Form etc
- Prepare the submission to the Independent Ethics Committees (central and local) and when applicable to Competent/Regulatory Authorities
- Travel to research sites as needed.
- Attend project-specific training and client meetings as needed for the clinical trial.
- Create materials as needed to successfully execute assigned responsibilities.
- Perform source data verification, review regulatory documents and study drug, and prepare trip reports as outlined in the Monitoring Plan.
The ideal candidate should have a Bachelor's degree but a RN may be considered. Prefer scientific discipline and multiple therapeutic experiences.1-3 years of monitoring experience or combination of on-site monitoring and clinical research experience or education; industry certification preferred. The ability to perform national travel up to an average of 80%, depending on project needs. The candidate must have excellent verbal and written communications skills; excellent interpersonal and organizational skills with demonstrated attention to detail. The candidate must be computer literacy with proficiency in MS Office including Word, Excel, and PowerPoint.
Must be fluent in the language of the territory you are assigned to as well as written and oral English (any additional languages would be appreciated) What's in it for you?
Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:Our Culture:
https://careers.advancedgroup.com/embrace-our-culture Career Development Opportunities:
https://careers.advancedgroup.com/realize-your-potential Community Programs:
For a complete list of all of our job openings, please visit Advanced Group's career site here .
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This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.