Research Coordinator - Department of Medicine, Division of Allergy & Infectious Diseases

Job Description

The Department of Medicine, Division of Allergy and Infectious Diseases has an outstanding opportunity for Research Coordinator to join their team.

Reporting to the Research Manager, the Research Coordinator provides professional-level support for clinical, biomedical, and behavioral research studies involving human participants. The position coordinates study implementation, participant activities, regulatory documentation, and clinical research data in support of UW Positive Research. UW Positive Research conducts rigorous human-centered research focused on HIV treatment, HIV remission/cure, and related comorbidities and co-infections. Our work is guided by cutting-edge science, Community Advisory Board input, and partnerships with patients, providers, collaborating institutions, and community-based organizations.

• Clinical Research Study Coordination - 30% Coordinate the day-to-day implementation of multiple clinical, biomedical, and behavioral research studies involving human participants. Develop and verify study procedures and assist investigators with study design, protocol implementation, and execution. Track study activities and participant progress to ensure that protocol requirements, assessments, laboratory testing, procedures, and treatments are completed accurately and on schedule. Identify operational or protocol-related concerns and recommend corrective action in consultation with investigators and study leadership.
• Participant Recruitment, Enrollment, and Management - 25% Recruit, screen, and enroll research participants in accordance with approved study protocols. Participate in evaluating participant eligibility using protocol criteria, medical information, interviews, observations, and study-specific assessments. Explain study objectives, procedures, potential risks, and participation requirements to prospective participants and their families. Develop and maintain informed-consent materials and obtain appropriately completed informed-consent documentation. Coordinate participant visits, follow-up activities, laboratory assessments, diagnostic procedures, and treatment plans.
  
  Respond to participant questions and concerns and facilitate communication among participants, clinicians, investigators, and study staff.
• Regulatory Compliance and Study Documentation - 20% Maintain accurate and complete regulations, Institutional Review Board, protocol, and informed-consent documentation. Ensure that research activities comply with approved protocols, institutional requirements, sponsor expectations, and applicable regulatory standards. Prepare and maintain source documentation and other required study records. Assist with IRB submissions, modifications, renewals, reports, and responses to regulatory or protocol-management issues. Coordinate and facilitate sponsor and study-monitor visits and respond to requests for documentation or corrective action.
• Clincial Data and Safety Management - 20% Collect, review, evaluate, and enter study data into paper case-report forms, electronic case-report forms, and other study databases. Review study records for accuracy, completeness, consistency, and timely completion. Evaluate and interpret collected clinical information in consultation with the principal investigator, as appropriate. Assess, document, and report adverse events and other participant-safety concerns in accordance with protocol and regulatory requirements.
  
  Determine when participant concerns or clinical findings require escalation to an investigator or physician and assist with implementing approved protocol adjustments.
• Program and Team Support - 5% Participate in research-team meetings, training activities, quality-assurance reviews, and process-improvement efforts. Collaborate with investigators, clinicians, research coordinators, community partners, and other internal and external stakeholders. Perform other related duties as assigned.

To be considered for this opportunity, your application must demonstrate that you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration. Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Manager.

• Minimum Qualifications Bachelor's degree in a related field and one year of relevant experience.
• Experience coordinating clinical or human-subjects research activities.
• Experience maintaining research documentation and working in accordance with study protocols and regulatory requirements.
• Demonstrated ability to manage multiple studies, participants, priorities, and deadlines with a high level of accuracy.
• Strong organizational, problem-solving, and written and verbal communication skills.
• Ability to communicate effectively and respectfully with research…