Clinical Research Associate, Various Levels

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform and coordinate different aspects of the clinical monitoring and site management process. • Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. • Manage procedures and guidelines from different sponsors and/or monitoring environments. • Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs. • Ensure audit readiness and develop 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. • Assess 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. • Maintain regular contact between monitoring visits with investigative sites. 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 with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. • Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. • Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the team as required. • Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. • Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.

🎯 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. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. • 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

• Flexible work arrangements • Professional development opportunities