ICON Strategic Solutions
Senior CRA Vaccines- FSP
ICON Strategic Solutions, Kansas City, Missouri, United States, 64101
Senior Clinical Research Associate (CRA) Job Description
The Senior CRA will monitor the progress of clinical studies at investigative sites or remotely, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Responsibilities
Apply knowledge of ICON’s policies and procedures.
Demonstrate excellent written and oral communication skills.
Maintain comprehensive knowledge of ICH / GCP guidelines.
Manage investigative sites to facilitate trial deliverables.
Escalate issues appropriately.
Conduct monitoring visits to confirm subject safety and data integrity.
Understand and demonstrate principles of IP accountability.
Identify scientific misconduct at the site level.
Utilize Microsoft Office, Clinical Trial Management Systems, IVRS / IWRS, and Electronic Data Capture platforms effectively.
Mentor new CRAs within the company.
Serve as an observation visit leader.
Conduct monitoring evaluation visits.
Assist team lead in developing trial tools or documents.
Support CTM tasks.
Participate in developing process improvements.
Present at client and investigator meetings.
Provide training to trial teams.
Our Commitment At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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Responsibilities
Apply knowledge of ICON’s policies and procedures.
Demonstrate excellent written and oral communication skills.
Maintain comprehensive knowledge of ICH / GCP guidelines.
Manage investigative sites to facilitate trial deliverables.
Escalate issues appropriately.
Conduct monitoring visits to confirm subject safety and data integrity.
Understand and demonstrate principles of IP accountability.
Identify scientific misconduct at the site level.
Utilize Microsoft Office, Clinical Trial Management Systems, IVRS / IWRS, and Electronic Data Capture platforms effectively.
Mentor new CRAs within the company.
Serve as an observation visit leader.
Conduct monitoring evaluation visits.
Assist team lead in developing trial tools or documents.
Support CTM tasks.
Participate in developing process improvements.
Present at client and investigator meetings.
Provide training to trial teams.
Our Commitment At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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