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Job #03159

About our client Our client is a leading Clinical Research Organization that established a reputation for delivering world-class pre-clinical and clinical services to life sciences companies of all sizes. The organization is experiencing unprecedented growth and has been cited by many industry analysts as holding an enviable market position for the foreseeable future. With a broad selection of interesting programs and an environment built to value the contributions of all employees, this is a great opportunity for the right candidate. Position Location Principal Investigator Washington Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee clinical conduct of Phase 0, 1 and 2 research studies by performing procedures as well as providing medical assessments, judgments and leadership in support of recruitment, screening and conduct of study while adhering to professional, regulatory and company standards 2) Remain competent in clinical skills and knowledge (ECG interpretation, IV administrating, phlebotomy and laboratory skills, etc.) 3) Ensure the welfare, health and safety of subjects 4) Advise sponsor organizations in the practical aspects of protocol 5) Maintain an understanding of study background, objectives, design and criteria as well as the investigational drug 6) Participate in pre-trial initiation meeting, routine site visits and closeouts with sponsor representatives 7) Oversee clinical conduct of all studies as well as planning, screening, qualification, orientation, medical history taking, physical examinations, review of test results, interpretation of ECGs and management of adverse events 8) Ensure that all studies are conducted properly to include proper admission and orientation, complying with the protocol, IRB requirements and all regulation 9) Ensure documentation is accurate and complete as well as address any quality assurance issues 10) Supervise the daily assessment of participants' well being 11) Participate in and manage all phases of adverse events (Aes) and related reporting 12) Render and/or prescribe treatment for adverse events (as necessary) 13) Approve recruiting folders before submission to sponsor 14) Review signed rules and regulations and informed consent forms for recruiting procedures 15) Fulfill protocol requirements with respect to presence in clinic for dosing and post-dose patient monitoring 16) Communicate with sponsor regarding adverse events and treatment 17) Review and sign CRFs or coordinate with Sub-investigator (as appropriate) 18) Participate in the writing and development of the final clinical summary, including final review and signature authorization 19) Prepare as well as participate in sponsor specific and regulatory audits 20) Participate in protocol assessment process and meetings 21) Be involved in operational planning meetings (as requested) 22) Participate in development of departmental training materials 23) Perform all other related duties as assigned Requirements 1) MD, DO or Pharm.D. 2) Current license to practice medicine in good standing in the State of Washington (or license in good standing in a state with Washington State reciprocity and submission for Washington State license in process) or PharmD license 3) Basic Life Support certification 4) Certified Principal Investigator or Documentation of NIH and GCP training preferred 5) Residency training in recognized medical specialty or post Pharm.D training 6) Previous experience in research with human subjects preferred 7) In-depth knowledge of FDA regulations, GCPs, GLPs, SOPs and policies 8) Excellent organizational and time-management skills 9) Superb computer skills (word processing and spreadsheets) 10) Excellent delegation skills and teaching skills 11) Ability to handle medical emergencies 12) Ability to function independently within a team environment