- Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, and providing instructions to site personnel and study close out.
- Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
- Ensures the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
- Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
- Verifies proper management and accountability of Investigational Product (IP).
- Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
- Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assists with resolution of investigational site/data queries.
- Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
- Participates in audit preparation and follow-up activities as needed.
- Independently performs a variety of onsite and offsite monitoring visit types.
- Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
- Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
- May serve as preceptor, providing training to less experienced clinical team members
- 2 years of experience supporting clinical trials including 1 year of on-site monitoring experience
- In-depth knowledge of the drug development process
- In-depth knowledge and practical utilization of ICH- GCP and applicable regulatory requirements
- Sound knowledge of applicable policies and procedures, SOPs, work instructions and other guidance documents
- Good spoken and written communication skills; good presentation skills
- Strong interpersonal, collaboration and time management skills
- High proficiency with Microsoft Office and company collaboration applications
- Excellent skill in the utilization of applicable clinical systems
- Excellent critical thinking skills
- Excellent organizational skills
- Ability to focus on detail for extended periods of time; high attention to accuracy
- Ability to travel extensively
- Ability to establish and maintain effective working relationships with investigative site staff
- Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse
- Equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.
- 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
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clinical research associate- ca/az - Phoenix, AZ, United States - ICON Clinical Research
Description
ICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and all applicable regulatory requirements.
What you will be doing:
You are:
_Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level._
Thank you
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits.
Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
ICON:
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment.
All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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