Clinical Trials Specialist

Job Description:Clinical Trial SpecialistBasic Qualification:5 years in life sciences or medically related field, including 2 to 3 years Clinical Development/Industry experience (eg CRA, CTS equivalent)Strong interpersonal skills and communication skills (both oral and written) along with good organizational and planning skills. Ability to deal with time demands, incomplete information or unexpected events and work effectively in a team/matrix environment. Other skills include advanced computer skills, experience with administration of site budgets and grants with supervision and experience with reviewing adequacy of site-proposed informed consents for compliance with relevant regulations.Job Summary:The Clinical Trial Specialist/Senior Clinical Trial Specialist will coordinate the activities associated with the evaluation, initiation and management of Clinical Development clinical trials. Write or contribute to preparation of clinical protocols, amendments, consent forms, study guides, CRFs, and any other clinical research related documents. Coordinate the activities associated with site start-up and overall trial management. Conduct the initiation and monitoring of assigned clinical trials. Manage the site conduct, and overall investigational product accountability and reconciliation process. Ensure compliance with Clinical Development policies and procedures. Recruit and approve clinical investigators. Ensure the collection and maintenance of essential documents, resolve patient eligibility and protocol deviation issues. Assist in preparation of Clinical Study Reports, annual IND safety reports.Please e-mail your resume for immediate consideration to phoward at our office onsite at Amgen: or phoward@amgen. You can view all of our jobs online at http://www.act-1.com/?sc=11



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