Clinical Research Associate - Level I

October 15

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• Performs and coordinates different aspects of the clinical monitoring and site management process • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation • Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSP, Government, etc.) • Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability • Ensures audit readiness • Develops collaborative relationships with investigational sites • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities • Assesses investigational product through physical inventory and records review • Documents observations in reports and letters in a timely manner using approved business writing standards • Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution • Conducts monitoring tasks in accordance with the approved monitoring plan • Participates in the investigator payment process • Investigates and follows-up on findings as applicable • Initiates clinical trial sites according to the relevant procedures to ensure compliance

Requirements

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 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 • Knowledge, Skills, Abilities: Basic medical/therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Good interpersonal skills • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Ability to remain flexible and adaptable in a wide range of scenarios • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills

Benefits

• competitive remuneration • annual incentive plan bonus • healthcare • a range of employee benefits