Senior Clinical Research Associate
il y a 6 jours
Advanced Clinical is recruiting for an inspiring biotechnology company focused on rare diseases. You will be an experienced CRA looking for their next step into complex disease areas.
In collaboration with our client, the Senior Clinical Research Associate (SCRA) is responsible for developing and maintaining the relationship with the site. The SCRA is the main point of contact for the site and is responsible for knowing all aspects of the site's capabilities and structure, being an expert on their sites. In addition, the SCRA will perform all site management and monitoring activities at clinical site(s). The SCRA 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 SCRA 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 client such as safety/pharmacovigilance, regulatory, clinical trial supply, etc.
The SCRA will be assigned clinical monitoring activities in a single country or several countries, ensuring appropriate clinical study conduct.
The SCRA will ensure subject safety and verify diligence in protecting the confidentiality of each subject.
The SCRA shall guarantee the adequacy, reliability, and quality of the data collected from sites and participate in the quality control processes.
The SCRA 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 SCRA must anticipate, recognize, and resolve issues for the assigned study sites.
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality and 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.
From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
Seniority level- Mid-Senior level
- Full-time
- Research, Management, and Project Management
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