Senior Clinical Monitoring Specialist
hace 2 semanas
Clinical monitoring is a vital part of ensuring the integrity and quality of clinical trials. As a Senior Clinical Monitoring Specialist at Thermo Fisher Scientific, you will be responsible for overseeing the implementation of risk-based monitoring strategies to identify potential site processes failures and ensure data accuracy.
About the Role:
We are seeking an experienced and skilled individual to join our team as a Senior Clinical Monitoring Specialist. In this role, you will be responsible for monitoring investigator sites with a risk-based approach, applying root cause analysis, critical thinking, and problem-solving skills to identify site process failures and corrective/preventive actions. You will also ensure data accuracy through SDR, SDV, and CRF review, assess investigational products through physical inventory and records review, and document observations in reports and letters in a timely manner. Additionally, you will escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
Responsibilities:
* Monitor investigator sites with a risk-based approach, identifying potential site process failures and implementing corrective/preventive actions* Ensure data accuracy through SDR, SDV, and CRF review, assess investigational products through physical inventory and records review, and document observations in reports and letters in a timely manner* Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution* Participate in investigator meetings as necessary, help identify potential investigators, and initiate clinical trial sites according to relevant procedures* Conduct on-site file reviews as per project specifications, provide trial status tracking and progress update reports to the team as required, and ensure study systems are complete, accurate, and updated per agreed study conventions* Facilitate effective communication between investigative sites, the client company, and internal project teams through written, oral, and/or electronic contacts, respond to company, client, and applicable regulatory requirements/audits/inspections, and maintain and complete administrative tasks such as expense reports and timesheets in a timely manner
Requirements:
* Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification* Minimal clinical monitoring experience that provides knowledge, skills, and abilities to perform the job (comparable to 1-2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research, or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered* Valid driver's license where applicable* Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents, good oral and written communication skills, ability to communicate effectively with medical personnel, good interpersonal skills, ability to maintain customer focus, and well-developed critical thinking skills including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem-solving* Salary: $85,000-$110,000 per year
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