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Job #02873

About our client Our client is a rapidly growing specialty biopharmaceutical company headquartered in Maryland that is focused on the development of bio-lipid based therapeutics. The company has an experienced management team, marketed products and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Research Associate Maryland Salary Highly competitive package, commensurate with experience Responsibilities 1) Monitor clinical trials’ progress (site management/monitoring perspective) while ensuring SOP, protocol, ICH and GCP compliance 2) Set-up and maintain an in-house Clinical Trial Management System (CTMS) for ongoing projects 3) Coordinate efforts from study start-up through closeout, including collection and reviewing of regulatory documents 4) Provide initial review of monitoring trip reports 5) Ensure timely, accurate and complete reporting of study conduct 6) Identify and document critical issues proactively, bringing them to the attention of study management personnel 7) Develop and maintain SOPs for monitoring functional area 8) Serve as a resource for questions related to monitoring, administrative tasks and SOPs/business processes 9) Interact directly with CROs, contractors and other vendors to ensure consistent implementation and successful completion of clinical research activities for studies 10) Assist with budget and contract reviews 11) Maintain and track budgets for selected ongoing clinical studies 12) Provide initial review of monitor expense reports, ensuring accurate and complete reporting of all expenses 13) Identify innovative solutions to accomplish objectives while maximizing resource and budget utilization within the organization 14) Work on new technologies and systems (i.e. eCRFs, ePRO tools) 15) Ensure that the monitoring staff is fully trained and has ability to train site personnel for meeting study requirements 16) Participate (with study management personnel) in designing and developing clinical protocols 17) Create project-specific documents and tools (e.g. monitoring plans, newsletters, Investigator meeting materials, training materials and drug accountability logs) to manage and monitor the study 18) Assist with identification and recruitment activities for investigative sites 19) Participate in pre-study and site initiation planning 20) Act as a first-line contact for field and/or study site personnel as well as study protocol and/or study conduct questions (as required) Requirements 1) BS/BA in a health-related field 2) ACRP-CRA certification a plus 3) 1 – 4 years of experience in a clinical research role (pharmaceutical industry) 4) Minimum 2 years of in-house CRA experience 5) In-depth knowledge of ICH/GCP guidelines 6) Expertise in Electronic Data Capture (EDC) systems and CTMS preferred 7) Ability to work within a team environment 8) Highly organized, with ability to multi-task 9) Proficiency in computers (MS Word, MS Excel and MS Project) 10) Excellent communication skills (written and verbal)