30 applicants

Company

Original Job Post

Thermo Fisher Scientific · 2 days ago

Sr CRA/Principal CRA - Cell or Gene Therapy

Austin, TX

Full-time

Onsite

Senior Level

2+ years exp

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BioinformaticsBiotechnology

H1B Sponsorship

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Responsibilities

Performs and coordinates all 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.

Ensures audit readiness and develops collaborative relationships with investigational sites.

Monitors investigator sites with a risk-based monitoring approach and applies root cause analysis to identify and resolve compliance issues.

Assesses investigational products through physical inventory and records review.

Escalates observed deficiencies and issues to clinical management and follows through to resolution.

Conducts monitoring tasks in accordance with the approved monitoring plan and participates in the investigator payment process.

Ensures completion of administrative tasks such as expense reports and timesheets in a timely manner.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Clinical monitoringMedical terminologyICH GCPsRisk based monitoringMicrosoft Office proficiencyEnglish language skillsProblem solvingCritical thinkingCustomer focusInterpersonal skillsAttention to detailFlexibilityAdaptabilityTime managementCommunication skillsTeamwork

Required

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years as a clinical research monitor)

Valid driver's license where applicable

Proven clinical monitoring skills

Demonstrated understanding of medical/therapeutic area knowledge and medical terminology

Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents

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

Good oral and written communication skills, with the ability to communicate effectively with medical personnel

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

Effective interpersonal skills

Attention to detail

Ability to remain flexible and adaptable in a wide range of scenarios

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

Good presentation skills

Company

Thermo Fisher Scientific

Glassdoor

3.6

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Founded in 1956

Waltham, Massachusetts, USA

10,001+ employees

http://www.thermofisher.com

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (173)

2022 (314)

2021 (349)

2020 (251)