Job Description

Principal Investigator - Clinical Research With the expansion of a new site, the Principal Investigator will oversee all aspects of clinical trials, ensuring adherence to regulatory guidelines and study protocols. This is a full-time or part-time role located in the Greater Seattle Area. Day-to-day tasks include managing all activities relating to clinical studies, recruiting and enrolling participants, supervising the clinical research team, monitoring patient safety, managing data collection and analysis, and preparing trial reports. The PI will also liaise with sponsors, regulatory bodies, and ethics committees to ensure successful study outcomes. Primary Responsibilities Clinical Studies Act as Principal Investigator on new and ongoing studies Be responsible for continuing conduct and completion of clinical studies Manage the activities and performance of the clinical staff and physicians affiliated with all studies to ensure compliance with established company policies and standard operating procedures, all study protocols, good clinical practices and quality standards Participate in recruitment, interviewing, selection, training and performance reviews of all clinically related staff Assure and monitor the adequate response to medical outcomes of study participants, including medical emergencies Supervise all clinical study and study functions, ensuring that all study participants are served in a friendly, appropriate and responsible manner Focus site activities on recruiting and retaining qualified study participants that meet or exceed the contractual requirements established by sponsors Quality and Education Manage the implementation of and ensure adherence to company policies, documents, and procedures, including its standard operating procedures Assist in the establishment of and be responsible for compliance with quality assurance programs which audit compliance with the standards and regulations of the US FDA and other relevant governmental agencies and manage any related audits Implement an education and training program for all incoming study coordinators, technicians, and clinical support personnel Site Operations Participate in the development and implementation of a management and reporting structure Cooperate with and assist in the conduct of any investigation, claims or litigation involving current or former employees Participate in monthly management reviews Assure appropriate staffing to competently support company administrative and operating procedures Participate in the hiring, supervision and direction of appropriate staff Participate in the expansion and continued development of technology required to support the business Qualifications Extensive experience in clinical trial design, patient recruitment, and data management Strong knowledge of regulatory requirements, Good Clinical Practice (GCP), and IRB processes Excellent leadership and team management skills Proficiency in medical research methodologies and statistical analysis Excellent written and verbal communication skills MD or DO in a relevant field with board certification preferred Board certification in Neurology, Psychiatry or Internal Medicine preferred Ability to work on-site in the Greater Seattle Area Company Description Founded in 1991, Rainier Clinical Research Center has conducted over 700 Phase I-IV clinical trials involving thousands of patients. Initially focusing on diabetes and its complications, we have expanded our research to include a wide range of medical conditions. Our facilities include an inpatient Phase I unit, enabling comprehensive research capabilities. Located in Renton, WA, we are dedicated to advancing medical knowledge through rigorous clinical trials. If you have additional questions, please contact Jay Koh at jkoh@rainier-research.com Seniority level: Director Employment type: Contract Job function: Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr Rainier Clinical Research Center

Job Tags

Similar Jobs