Job Description
Join NovoMed Therapeutics, a leader in innovative pharmaceutical solutions, as a Clinical Research Associate. We're seeking a meticulous professional to ensure the integrity of clinical trials while advancing groundbreaking therapies. This role offers the opportunity to work with cutting-edge treatments in a collaborative, research-driven environment. If you're passionate about accelerating drug development and maintaining the highest ethical standards, we want you on our team.
Responsibilities
- Monitor clinical trial sites for protocol compliance and regulatory adherence
- Conduct site visits and audits to ensure GCP standards are met
- Manage trial documentation, including CRFs and regulatory submissions
- Collaborate with investigators to resolve site-specific issues
- Analyze and report clinical data with precision and accuracy
- Coordinate study initiation, execution, and closure activities
- Maintain strong relationships with sponsors and regulatory bodies
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- Certified Clinical Research Associate (CCRA) certification required
- 3+ years of clinical monitoring experience in pharmaceutical trials
- Deep knowledge of ICH-GCP, FDA, and EMA regulations
- Exceptional attention to detail and documentation skills
- Strong analytical and problem-solving abilities
- Ability to travel up to 30% domestically
- Experience with EDC systems (e.g., Medidata Rave) preferred