Clinical Research Coordinator III

WACBD - Washington Center for Bleeding Disorders•Seattle, WA

About The Position

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.

Requirements

Bachelor’s degree in biology science or health related field or equivalent education and experience.
5 years clinical research experience or equivalent
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
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

Nice To Haves

Master’s degree in a related field preferred
Clinical research certification (e.g., ACRP, SOCRA) preferred
Experience with human subjects regulatory submissions strongly recommended; technical writing skills desired
Washington State Medical Assistant Phlebotomy license preferred
Knowledgeable and skilled in basic laboratory procedures for routine sample processing

Responsibilities

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