Clinical Research Associate
hace 4 semanas
Responsibilities:
As a Clinical Research Associate - Site Monitoring at Thermo Fisher Scientific, you will be responsible for monitoring investigator sites with a risk-based monitoring approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. You will ensure data accuracy through SDR, SDV, and CRF review as applicable through on-site and remote monitoring activities. Additionally, you will assess investigational product through physical inventory and records review, document observations in reports and letters in a timely manner using approved business writing standards, and escalate observed deficiencies and issues to clinical management expeditiously. You will also maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved, and that the data is being recorded in a timely manner.
Qualifications:
We are seeking a highly skilled and experienced clinical research associate who possesses a Bachelor's degree in a life sciences related field or a Registered Nursing certification, or equivalent, and a minimum of 1-2 years of clinical monitoring experience in a clinical environment. The ideal candidate will have a working knowledge of ICH GCPs, applicable regulations, and procedural documents, as well as excellent oral and written communication skills, with the ability to communicate effectively with medical personnel. Additionally, the candidate should have good interpersonal skills, the ability to maintain customer focus, and good organizational and time management skills. The ability to remain flexible and adaptable in a wide range of scenarios, well-developed critical thinking skills, including critical mindset and in-depth investigation for appropriate root cause analysis and problem-solving, and the ability to manage Risk Based Monitoring concepts and processes are also essential.
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