Clinical Research Associate
Há 4 dias
A clinical research associate plays a vital role in accelerating drug/device/outcomes research by independently monitoring studies to ensure patient safety and data integrity.
Our comprehensive clinical research program features extensive co-monitoring, fostering a supportive and collaborative work environment. Frequent and consistent communication with both internal teams and clients enables our program to be closely aligned on shared goals.
As a healthcare intelligence-powered organization, we aim to deliver high-quality clinical research services.
Main Responsibilities:- Complete onsite and remote monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, SOPs, and study processes including qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel, and study close-out.
- Verify the protection of study participants by confirming informed consent procedures and protocol adherence according to applicable regulations.
- Ensure the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
- Manage investigative site staff to facilitate trial deliverables e.g. subject enrollment, data submission.
- Verify proper management and accountability of Investigational Product (IP).
- Write and submit reports of investigational site findings and update applicable tracking systems escalating observed deficiencies issues and corrective and preventative actions as appropriate.
- Manage essential documents as required by local regulations and ICH-GCP guidelines before during and after a clinical study assist with resolution of investigational site/data queries.
- Perform key risk assessments and management responsibilities throughout the project including risk indicator and site health analysis site process evaluation and project escalation.
- Participate in audit preparation and follow-up activities as needed.
- Independently perform various onsite and offsite monitoring visit types.
- Gather and review information for assigned sites identify inconsistencies assess risk and escalate as appropriate with limited guidance.
- Assist with non-complex adhoc short-term assignments supporting additional studies or departmental initiatives.
- Hold an undergraduate degree or international equivalent in a clinical science or health-related field from an accredited institution healthcare professional licensure e.g. registered nurse.
- Have previous experience supporting clinical trials including solid onsite monitoring experience.
- Be willing to travel 50-80%.
- Equivalent education training and relevant experience may be considered all employees must read write and speak fluent English and the host country language.
Our success depends on the quality of our people we prioritize building a diverse culture that rewards high performance and nurtures talent.
In addition to a competitive salary, we offer a range of benefits focused on well-being and work-life balance for you and your family.
We strive to create an inclusive workplace free of discrimination and harassment where everyone feels valued and respected.
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