Sr. Clinical Research Associate

Há 1 mês

São Paulo, Brasil ICON 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 that enables 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.

Responsibilities:
  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 close out.
  2. Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to 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 site and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
  12. Assists with non-complex adhoc, short-term assignments in support of additional studies or departmental initiatives.
  13. May serve as preceptor, providing training to less experienced clinical team members.
Minimum Requirements:
  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. Based in São Paulo.
  4. Travel is required 50-80%.
  5. 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.
Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

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