Regulatory Affairs Specialist Clinical Trials
4 days ago
Alliance Clinical LLC is a leading organization in the field of clinical research, committed to advancing medical innovation and improving patient lives. Our team is comprised of dedicated professionals who share a passion for delivering high-quality research services.
Job Title:
Clinical Research Compliance Specialist
Job Description:
This is a unique opportunity to join our team as a Clinical Research Compliance Specialist. As a member of our team, you will play a critical role in supporting clinical research studies by ensuring protocol and regulatory compliance, reviewing research data for accuracy, and managing documentation and milestones. You will also be responsible for conducting audits, writing monitoring reports, and developing risk monitoring plans and study-related documents.
Responsibilities:
* Review and monitor research protocols and ensure adherence to regulatory requirements.
* Conduct on-site and remote audits to evaluate compliance and ensure human subject protection and data integrity.
* Develop and implement risk monitoring plans and study-related documents.
* Collaborate with the offshore compliance team and the onsite study team to address critical findings.
* Adhere to confidentiality and compliance standards.
Qualifications:
* Associate degree in healthcare or a related field preferred.
* Two (2) years of clinical research experience as a CRC or one (2) years of experience as a CRA.
* Proficient in Microsoft Word, Excel, and Adobe Acrobat.
Salary and Benefits:
The salary for this position is estimated to be around $85,000 per year, including benefits such as medical, dental, vision insurance, 401(k) retirement plan with a company-match, paid time off, and company holidays.
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