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Senior Clinical Research Associate
Il y a 4 mois
Advanced Clinical is recruiting for an inspiring biotechnology company focused on rare diseases. You will be an experienced Senior CRA looking for their next step into complex disease areas.
In collaboration with our client, the senior Research associate (SCRA) is responsible for developing and maintaining the relationship with the site. The Senior Clinical Research Associate is the main point of contact for the site. It will be responsible for knowing all aspects of the site's capabilities and structure and being an expert on their sites. In addition, the Senior Clinical Research Associate will perform all site management and monitoring activities at a clinical site(s). The Senior Clinical Research Associate will ensure clinical studies are performed according to the study protocol, standard operating procedures and associated plans, relevant local and internal regulations, legislation and ICH/GCP guidelines.
The Senior Clinical Research Associate will serve as the single point of contact for the assigned sites throughout the study lifecycle and develop and maintain the relationship pre- and post-study timelines. This includes but is not limited to feasibility, study start-up, essential document/TMF maintenance, etc., supporting the site and other functional areas of the internal clients such as safety/pharmacovigilance, regulatory, clinical trial supply, etc.
The Senior Clinical Research Associate will be assigned clinical monitoring activities in a single country or several countries, ensuring appropriate clinical study conduct.
The Senior Clinical Research Associate will ensure subject safety and verify diligence in protecting the confidentiality of each subject.
The Senior Clinical Research Associate shall guarantee the adequacy, reliability and quality of the data collected from sites and participate in the quality control processes.
The Senior Clinical Research Associate will ensure that the study's conduct complies with the currently approved protocol/amendment(s), ICH GCP, SOPs and any applicable regulatory requirements in the assigned countries.
The Senior Clinical Research Associate must anticipate, recognize and resolve issues for the assigned study sites.
Advanced Clinical is a global clinical development organisation that provides CRO, FSP, Quality and validation, and Strategic Resourcing services for biopharmaceutical and medical device organisations. 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.
From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
Advanced Clinical
A Better Clinical Experience
