We are looking for all levels of CRA's including levels I, II, and Senior. These opportunities are for seasoned CRAs, please do not respond if you do not have at least 1 year of field monitoring experience.There opportunities are contract and permanent.
Responsibilities
The Regional CRA is responsible for site qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies in accordance with country-specific regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes. This role will identify, evaluate, and recommend new/potential investigators/sites on an on-going basis; expedite pre-study processes and Site Initiation Visits (SIVs); conduct SIVs and training of study site personnel regarding the protocol and applicable regulatory requirements in collaboration with pertinent project team members. The Regional CRA will conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives.
Requirements
•Bachelor's degree; a medical, science, or nursing background is preferred
•Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials
•Advanced and thorough knowledge related to ICH/GCP Guidelines
•Experience in on-site monitoring of investigational drug trials with demonstrated strong site management and monitoring skills
•Exhibited strong planning and organizational skills
•Attention to detail, strong interpersonal skills, excellent verbal and written communication skills
•Acute observational skills, analytical and conceptual capabilities
•Competence in the use of personal computers, including MS Office, email and web applications
•Previous experience with electronic data capture systems is desirable
•Strong ability to work independently with minimal supervision
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It is NOT ok to contact this poster with commercial interests.
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Regional CRA
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