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Job #03343

About our client Our client is a well-established CRO with an experienced management team and a loyal customer base. They have developed an industry-wide reputation for a positive work environment and an aggressive training program that ensures employees are up-to-date on current trends and best practices. This is a strong opportunity for someone that wants to put their drive and initiative to work. Position Location Senior Clinical Research Associate Louisiana Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee start-up of clinical trials, including those of the company's projects in India 2) Handle protocol and CRF development as well as implementation 3) Manage development of trial-related documents and operational procedures as well as regulatory document collection and document filing 4) Handle pre-study site evaluations, clinical investigational site monitoring and close-out as well as clinical investigational site training 5) Manage clinical investigational site recruitment as well as negotiation of clinical trial agreements and grants 6) Supervise adverse event reporting 7) Ensure that data collected is accurate and verifiable 8) Handle resolution of clinical investigational site queries 9) Ensure drug shipments and accountability 10) Review site study files 11) Assist in the evaluation, selection and monitoring of CROs and other vendors based on the scope of work 12) Establish performance metrics for the trial and contribute to training of Vendor staff (as appropriate) 13) Monitor/co-monitor multiple investigational sites for therapeutic areas in accordance with state and federal regulations, GCPs and internal SOPs 14) Train and mentor junior level Clinical Research staff 15) Review (independently) SAE reports and clinical study reports with associated study tables, listing and figures Requirements 1) BS in Life Sciences 2) Minimum 7 years of clinical research experience with 4 – 5 years of direct monitoring experience 3) Excellent understanding of the clinical development process, GCPs and ICH guidelines 4) Knowledge of therapeutic areas (oncology, transplantation or immunology) 5) Excellent communication (written and oral), negotiation, influencing, IT (MS Office), networking and interpersonal skills 6) Ability to work within a global team framework and a multi-cultural environment 7) Ability to work strategically, political savvy and strong technical knowledge 8) Willingness to travel domestically and/or internationally (up to 40%)