Clinical Research Coordinator III

As a recognized Hemophilia Treatment Center and a Center of Excellence, the Washington Institute for Coagulation d/b/a Washington Center for Bleeding Disorders (WACBD), is committed to the wellbeing of patients with an inherited bleeding disorder across the State of Washington, neighboring states, and Alaska. Our staff is an ensemble of dedicated healthcare professionals and support personnel that are striving to ease the burden that bleeding disorders have placed upon our patients. About the role Under the supervision of the Director of Research Administration, the Clinical Research Coordinator III (CRC III) independently manages significant and key aspects of complex multi-site protocols and/or all aspects of one or more smaller trials or research projects. Interfaces with research participants and resolves issues related to study protocols. Interfaces with study sponsors, monitors and reports SAEs; resolves study queries. Trains and provides guidance to less experienced staff. Authorizes purchases for supplies and purchased services. Provides leadership in determining, recommending, and implementing improvements to policies/processes. Assists in developing study budgets, grant proposals and protocols. Periodically audits operations to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes. May perform supervisory duties and other special projects as assigned by the Director of Research Administration. What you'll do Demonstrates knowledge and understanding of Good Clinical Practice, ICH guidelines, Good Documentation Practice and HIPAA regulations in relation to human subjects research. Becomes familiar with WIC Research Policies and Procedures related to Research Develops and maintain a professional relationship with research subjects their families; ensures protection of their rights as research participants, serves as a resource for clinical research information Ensures compliance with protocol and regulatory requirements; prepares and manages Institutional Review Board, Investigational New Drug and/or other required regulatory submissions; ensures the regulatory binder is current and accurate Manages study procedures including screening for and recruitment of potential subjects; conducts informed consent discussion; implements and coordinates procedures to collect data from patient medical records, interviews, questionnaires, diagnostic tests and other sources; completes paper or electronic case report forms; collects, processes and transports/ships biological specimens; manages drug accountability; resolves queries; responds to sponsor requests; documents all study procedures accurately and in a timely manner, including but not limited to documentation of research subject eligibility and informed consent. Identifies, documents and reports protocol or data problems and/or inconsistencies; monitors research subject progress including documentation and reporting of adverse and serious adverse events; recommends corrective action as appropriate Prepares team study team and study site for site initiation, monitor visits, sponsor audits, regulatory audits and any other type of site visit requested by study sponsor or regulatory agency Performs in depth review of protocol/protocol synopsis including risk/benefits analysis and present analysis/synopsis to study team for discussion and review Provides feedback to management of research project progress/scope or budget changes/new research opportunities and escalating issues when they impact study participant safety, timeline, scope, quality of research or budget Participates in the development, training, evaluation and refining and of standard operating procedures, study and team administrative templates Participates in sponsor and WIC required teleconferences, meetings, including patient rounds, and trainings (virtual or in-person, local or international) Manages work in a manner that allows timely completion of project assignments and team tasks Works closely with Research team members to ensure back-up coverage as needed Performs other duties as required Qualifications Bachelor’s degree in biology science or health related field or equivalent education and experience. Master’s degree in a related field preferred 5 years clinical research experience or equivalent Clinical research certification (e.g., ACRP, SOCRA) preferred Experience with human subjects regulatory submissions strongly recommended; technical writing skills desired Must have strong attention to detail, be highly organized, able to multi-task, manage competing priorities, work independently, take initiative to start and complete tasks Ability to interact effectively with professional, administrative staff, sponsor and regulatory representatives, patients, potential subjects, and referral sources Skilled at chart review and abstracting data from patient charts Washington State Medical Assistant Phlebotomy license preferred Knowledgeable and skilled in basic laboratory procedures for routine sample processing Proficiency and ability to effectively use Windows MS Word, MS Excel, MS Outlook, MS PowerPoint MS Edge or Google Chrome, facsimile machines, copiers, scanners and database software Proficiency with Electronic Medical Record databases and web-based electronic case report forms Willingness and ability to maintain appropriate level of confidentiality and privacy Current Washington State driver’s license and State-required insurance when using personal vehicle for business purposes Demonstrates consistently positive and professional communication with patients, research subjects, team members, community members, partner agencies, and all other stakeholders, while ensuring that Protected Health Information (PHI) is safeguarded in accordance with HIPAA and organizational policies. Required physical activities while using a laptop include frequent sitting, talking, hearing, and repetitive motions of hands/wrists Required physical activities include standing, walking, and reaching, kneeling, bending, and stooping Attendance at outreach clinics in Washington state, educational conferences, collaborative meetings, and organizational retreats The pay range for this role is: 85,000 - 95,000 USD per year(Home Clinic Address) Benefits: 401(k) Dental insurance Flexible schedule Flexible spending account Health insurance Health savings account Paid time off Vision insurance Work Location: In person