Summary:

Oversee clinical conduct of Phase 0, I and II research studies by performing procedures and providing medical assessments, judgments and leadership in support of recruitment, screening and conduct of study, while adhering to professional, regulatory and company standards. Responsible for the welfare, health and safety of subjects

Essential Duties and Responsibilities: 

• Advise sponsor organizations in the practical aspects of protocol.

• Understand study background, objectives, design and criteria and have full understanding of/familiarity with the investigational drug

• Participate in pre-trial initiation meeting, routine site visits and close-outs with sponsor representatives.

• Oversee clinical conduct of all studies, to include: planning, screening, qualification, orientation, medical history-taking, physical examinations, review of test results, interpretation of ECGs and management of adverse events.

• Ensure that all studies are conducted properly, to include: proper admission and orientation; complying with the protocol, IRB requirements and all regulations; assuring documentation is accurate and complete; and addressing any quality assurance issues.

• Supervise the daily assessment of participants’ well being.

• Participate in and manage all phases of adverse events (AE)s and related reporting; render and/or prescribe treatment for adverse events as necessary.

• Approve recruiting folders before submission to sponsor; review signed rules and regulations and informed consent form for recruiting procedures.

• Fulfill protocol requirements with respect to presence in clinic for dosing and post-dose patient monitoring.

• Communicate with sponsor regarding adverse events and treatment.

• Review and sign CRFs, or coordinate with sub-investigator as appropriate.

• Participate in the writing and development of the final clinical summary, including final review and signature authorization of same.

• Prepare and be available for sponsor specific and regulatory audits.

• Participate in calendar, protocol assessment process and meetings.

• Participate in operational planning meetings as requested.

• Participate in development of departmental training materials.

• Perform all other related duties as assigned.

Qualifications:

• M.D. or D.O.   Residency training in recognized medical specialty, or post PharmD training.

• Previous experience in research with human subjects preferred.

• Must have 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.  Basic Life Support certification. Certified Principal Investigator or Documentation of NIH and GCP training preferred.

• Remain competent in clinical skills and knowledge (i.e., ECG interpretation, IV administration, phlebotomy and laboratory skills, etc.).  Excellent working knowledge of FDA regulations, GCPs, GLPs, SOPs and Policies.  Must be able to handle medical emergencies. Solid computer skills, especially word processing and spreadsheets.  Must be able to function independently within a team environment.  Excellent organizational and time-management skills.  Excellent delegation skills and teaching skills.

Physical Demands:

• While performing the duties of this job, the employee is regularly required to talk, hear and work/type at a computer. 

• Specific vision abilities required by this job include close vision and the ability to adjust focus.

• General office working conditions, the noise level in the work environment is usually quiet.

• Occasionally exposed to fumes or airborne particles.

• At risk of exposure to bodily fluids or blood borne pathogens.