Catawba Research is in search of a Texas-based Clinical Research Associate. The candidate must live in a major metropolitan city within the state of Texas. Up to 80% travel monthly.
Summary: The Clinical Research Associate (CRA) is responsible for clinical monitoring activities as part of a clinical trial team. The CRA serves as liaison between the Project Manager, Clinical Trial Assistants and clinical trial sites. They are integral in the documentation capture process ensuring all information is secured and accurate at both site and CRO levels.
- Travel to clinical trial sites to provide clinical monitoring throughout the lifecycle of a pharmaceutical study from feasibility determination to close-out
- Supervises on-site conduct of clinical studies acting as liaison between Project Manager and site personnel
- Ensures quality execution of clinical trial by verifying materials and data integrity, ensuring every trial is “audit ready” at all times
- Verifies integrity of investigator/site files ensuring compliance and completeness of documentation at the site level
- Report development to ensure proper documentation of site visits and study conduct
- Assesses protocol adherence and implementation at sites throughout the conduct of a clinical trial
- Ensures compliance with patient informed consent process
- Verifies receipt, handling, accounting, storage, and availability of investigational product
- Verifies compliance and quality of collected data through site visits and ongoing query management
- Ensure compliance with procedures related to serious adverse events
- Verifies investigator records and checks for consistency with Trial Master File and Individual Site Files
- In cooperation with PM and CTA, ensures timely collection of documentation from trial sites
- Develops timely reports for submission and approval throughout the lifecycle of the clinical trial
- Ensures completeness and accuracy of reports, as well as site visit letters and other forms of documentation
- A Bachelor’s Degree in biomedical sciences, pharmacy, pharmacology, nursing or a related discipline and/or a minimum of two years’ experience as a CRA; combination of relevant experience and education acceptable
- Excellent oral and written communication skills
- Excellent interpersonal skills
- Ability to work independently
- Ability to travel extensively
- Detail-oriented and highly organized
- At least two years’ experience working in clinical trials from study start-up to closeout
- Knowledge and proficient use of CTMS, EDC, project management software, and other technology-based programs (including Microsoft Office programs)
- Knowledge of applicable clinical research regulatory requirements (i.e., GCP and ICH Guidelines)
- Mindset of superior customer service for sponsors and sites
To apply, send a cover letter with salary requirements along with a resume to firstname.lastname@example.org. The application process for this position will close on Friday, January 19, 2019.
EOE: The above description is intended to describe the general nature of the job may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.