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Clinical Research Associate II
2 months ago
We are seeking a highly skilled Clinical Research Associate II to join our team at CPC Clinical Research. As a key member of our clinical trials team, you will be responsible for ensuring the smooth execution of clinical trials, from site initiation to close-out.
Key Responsibilities- Site Monitoring: Conduct regular site visits to ensure compliance with protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Drug Accountability: Oversee the storage, handling, and disposition of investigational products at clinical trial sites.
- Regulatory Compliance: Maintain accurate records of monitoring activities and regulatory documents, ensuring compliance with CPC's quality standards.
- Study Materials: Assist in the development and production of study-related materials, including case report forms, study procedure manuals, and source documents.
- Site Selection and Training: Collaborate with the clinical trials team to select qualified sites and investigators for research protocols, and provide training and support as needed.
- Education: Nursing or bachelor's degree preferred, but not required.
- Experience: Minimum of three years of experience in clinical trials research, with at least one year as a Clinical Research Associate.
- Skills: Thorough knowledge of GCP guidelines, FDA and ICH regulations, and the drug development process. Intermediate level of proficiency in MS Office, with experience in EDC and CTMS systems a plus.
- Personal Qualities: Excellent communication and interpersonal skills, with the ability to work independently and as part of a team. Strong organizational and time management skills, with attention to detail and ability to prioritize tasks effectively.
- Competitive Compensation: Targeted salary range of $66,000 - $80,000 annually.
- Comprehensive Benefits: Medical, dental, vision, life, and disability insurance, as well as a 401(k) plan with company match.
- Professional Development: Opportunities for training and professional growth, with a focus on developing your skills and expertise in clinical research.
CPC Clinical Research is a leading provider of clinical trial design, oversight, and management services. With over 30 years of experience, we have a proven track record of delivering high-quality clinical trials in a variety of therapeutic areas. Our team is dedicated to providing exceptional service and support to our clients, and we are committed to advancing the field of clinical research.