Clinical Research Associate
7 ore fa
About Mygwork
Mygwork is an inclusive employer and a member of the largest global platform for the LGBTQ+ business community. We pride ourselves on embracing diversity, promoting innovation, and fostering a culture of collaboration.
Job Summary:
We are seeking a highly skilled Clinical Research Associate to join our team in Rahway, NJ. As a key member of our operations, you will be responsible for ensuring the smooth execution of clinical trials while maintaining the highest standards of quality and compliance.
Key Responsibilities:
- Perform site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and associated documents.
- Conduct site visits, including validation visits, initiation visits, monitoring visits, close-out visits, and record clear, comprehensive, and accurate visit & non-visit contact reports.
- Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance.
- Identify, assess, and resolve site performance, quality, or compliance problems and escalate as needed in collaboration with CRA Manager, CRM, TA Head, and CRD.
Requirements:
To succeed in this role, you should have at least 3 years of direct site management (monitoring) experience in a bio/pharma/CRO, a B.A./B.S. with a strong emphasis in science and/or biology, and excellent communication skills, including the ability to understand and present technical information effectively.
Benefits:
We offer a competitive salary range of $60,000-$80,000 per year, a dynamic work environment, opportunities for professional growth and development, and a comprehensive benefits package.
About the Job:
This is a full-time position requiring 75% travel and a valid driving license. If you are a motivated and results-driven individual with a passion for clinical research, we encourage you to apply.
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