Clinical Research Associate Ii

Há 2 dias

Região Geográfica Imediata de Criciúma, Brasil buscojobs Brasil Tempo inteiro

A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity.

You will be joining a program that takes an extensive co-monitoring approach, enabling a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, positions our program to be closely aligned on our shared goals.

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.

  1. 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, providing instructions to site personnel, and study closeout.
  2. Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations.
  3. Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs.
  4. Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
  5. Verifies proper management and accountability of Investigational Product (IP).
  6. 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.
  7. 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.
  8. Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
  9. Participates in audit preparation and follow-up activities as needed.
  10. Independently performs a variety of onsite and offsite monitoring visit types.
  11. Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
  12. Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
  13. May serve as preceptor, providing training to less experienced clinical team members.

You Are:

  1. Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse.
  2. Previous experience supporting clinical trials including solid on-site monitoring experience.
  3. Travel is required 50-80%.
  4. 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.

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.

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 organization. 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.

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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