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Company

ICON Strategic Solutions · 3 days ago

Senior CRA

Georgia, United States

Full-time

Remote

Mid, Senior Level

4+ years exp

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Pharmaceutical Manufacturing

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Responsibilities

Management Clinical Trials according to the protocol and ICH GCP, standard operation procedures and monitoring plan.

Knowledge and understanding of the protocol and CRF content

Keeping contact with the Investigator.

Supporting sites with all issues concerning study.

Providing information to investigators about: protocol principles, study timelines, enrolment expectations and proposed fee.

Preparing and performing Initiation Visit and Monitoring Visit according to the GCP and monitoring plan.

Preparing Institution and Investigator fees documentation.

Qualification

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Clinical Trials ManagementICH GCP KnowledgeClinical Trial DesignMonitoring ExperienceFDA Regulations KnowledgeEMEA Regulations KnowledgeLife Science DegreePeople Management SkillsFluency in EnglishFluency in PolishFluency in GeorgianComputer LiteracyManaging Multiple Priorities

Required

Management Clinical Trials according to the protocol and ICH GCP, standard operation procedures and monitoring plan.

Knowledge and understanding of the protocol and CRF content

Keeping contact with the Investigator.

Supporting sites with all issues concerning study.

Providing information to investigators about: protocol principles, study timelines, enrolment expectations and proposed fee.

Preparing and performing Initiation Visit and Monitoring Visit according to the GCP and monitoring plan.

Preparing Institution and Investigator fees documentation.

A life science / healthcare related degree or equivalent work experience.

Minimum 4 year of independent monitoring experience (mandatory).

Solid understanding of clinical trial design, trial execution and operations.

Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations.

Expertise in communication, managing multiple priorities and computer literacy.

Proven people management skills with demonstrated expertise in working in a team.

Fluency in English as well as Polish.

Availability to travel at least 60% fly and drive and should possess a valid driving license.

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs

Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others