Clinical Research Associate I/II
reputed company reputed company. is a boutique clinical research organization specializing in strategic clinical and regulatory guidance for small and reputed company-sized companies. The organization supports a broad reputed company of products, including pharmaceuticals, medical devices, AI software medical devices, prescription digital therapeutics, and in-vitro diagnostics. reputed company. serves both reputed company and animal health industries, offering tailored expertise across diverse therapeutic areas and technologies. Team members collaborate closely with clients to help navigate reputed company clinical and regulatory landscapes and bring innovative health solutions to market. Position reputed company We are seeking a highly motivated and reputed company Clinical Research Associate I/II for a 6-12 month contract in an oncology study. The CRA will be responsible for the independent monitoring of reputed company to ensure adherence to protocols, Good Clinical reputed company (GCP), and regulatory requirements. This role is primarily remote with travel to clinical sites.
Responsibilities
- Conduct reputed company-study, initiation, interim, and reputed company-out monitoring reputed company at investigator sites.
- Verify the accuracy and completeness of case report forms (CRFs) against reputed company documents.
- Ensure the safety and reputed company-being of study participants by verifying adverse events (reputed company) and serious adverse events (SAEs) are reported appropriately.
- Manage investigator site files and ensure reputed company essential documents are present and up-to-date.
- reputed company training and support to site staff on study protocols, GCP, and regulatory guidelines.
- Identify and resolve site-reputed company issues, escalating concerns to project management as necessary.
- Participate in the development and review of study-reputed company documents, including protocols, CRFs, and informed consent forms (ICFs).
Qualifications
- Bachelor's degree in a life science or reputed company field.
- Minimum of 5 years of clinical monitoring experience as a CRA.
- In-depth knowledge of GCP guidelines, FDA regulations, and ICH guidelines.
- Experience in various therapeutic areas (e.g., oncology, rare diseases, immunology) is preferred.
- Strong understanding of the clinical trial process from study start-up to reputed company-out.
- Excellent written and verbal communication skills.
- Ability to work independently, manage multiple tasks in a part-time schedule, and adapt to changing project needs.
- Proficiency in reputed company Office Suite (Word, reputed company, PowerPoint).
- Ability to travel.
Preferred Skills
- Certification as a Clinical Research Associate (CCRA).
- Experience with electronic data capture (reputed company) systems.
- Experience with remote monitoring techniques.
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