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Job #02283

About our client Our client is a privately-held, emerging biopharmaceutical company focused on the discovery, development and commercialization of small molecule drugs to treat HIV and cancer. The company has strong pipeline, a solid management team and successful candidates can look forward to potential advancement within this growing organization. Position Location Senior Clinical Research Associate (Office Based) Texas Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the activities required to start up clinical trials such as protocol informed consent and CRF development, implementation, development of trial related documents and operational procedures, regulatory document collection and document filing 2) Oversee clinical investigational site recruitment, negotiation of Clinical Trial Agreements and grants, pre-study site evaluations, clinical investigational site monitoring, clinical investigational site closeout, clinical investigational site training, adverse event reporting, ensure that data collected is accurate and verifiable and resolution of clinical investigational site queries 3) Ensure drug shipments and accountability, review site study files 4) Assist in the evaluation, selection and monitoring of contract research organizations and other vendors based on the scope of work and established performance metrics for the trial Contribute to training of vendor staff as appropriate 5) Monitor/co-monitor multiple investigational sites for therapeutic area in accordance with State and Federal regulations, Good Clinical Practice regulations and internal Standard Operating Procedures 6) Review Serious Adverse Event reports, and clinical study reports with associated study tables, listing and figures 7) Monitor oncology clinical trials 8) Train and mentor junior level clinical research staff Requirements 1) Bachelor of Science degree (Life Sciences discipline and/or RN preferred) 2) 5 years of experience as a CRA 3) Demonstrated knowledge and understanding of FDA regulations and ICH guidelines governing the conduct of clinical trials 4) Valid driver’s license 5) Excellent clinical trials monitoring skills to include conduction of qualification, initiation, monitoring and close out visits 6) Ability to mentor and train other monitors in a positive and effective manner 7) Ability to communicate effectively with medical personnel 8) Ability to utilize problem-solving techniques applicable to constantly changing environment 9) Strong planning, decision making, and organizational skills 10) Strong customer focus and excellent interpersonal skills 11) Excellent oral and written communication skills 12) Demonstrated knowledge and understanding of MS Word, PowerPoint, MS Excel and MS Project 13) Willingness to travel up to – 45%