Research Coordinator - Montgomery

Title: Research Coordinator
Job Class: Hourly/Non-Exempt, $28.84 - $31.25 DOE
PI: Bruce Mongtomery, MD
Reports To: Jessica Brown

At the Seattle Institute for Biomedical and Clinical Research (SIBCR), scientists seek new ways to improve the health and well-being of Veterans through research and education conducted at the VA Puget Sound Health Care System (VAPSHCS). You will also enjoy outstanding benefits, professional growth opportunities, and the chance to be a part of an important mission.

SIBCR’s research spans a broad range of areas such as mental health; neuroscience; diabetes, endocrinology and nutrition; prosthetics; oncology; age-related diseases; and, pulmonary diseases. We are seeking a Research Coordinator for Dr. Bruce Montgomery's oncology research team.

Responsibilities:

Participant Management:

Conduct study specific procedures including but not limited to: screening patients, consenting patients for research studies, interviewing patients, administer questionnaires, monitor compliance, generating patient correspondence, scheduling appointments, and requesting labs and procedures (under the supervision of principal investigator). Evaluate/triage patient events and seek assistance for emergent issues.

Study Operations:

The Clinical Research Coordinator is responsible for developing familiarity with all study protocols and acts as the subject matter expert on all assigned studies. They coordinate study timelines and serve as the liaison between the local research team and stakeholders. Additionally, they are tasked with tracking and inventorying specimens for relevant studies, ensuring proper documentation and storage. The coordinator orders and maintains supplies needed for both routine and study-specific tasks, utilizing VA-specified ordering methods and guidelines to ensure efficiency and compliance

Data and Documentation:

In this role, the Clinical Research Coordinator establishes and maintains source documentation. They are responsible for entering data into computerized report forms and generating reports on a weekly, monthly, or ad hoc basis using software such as RAVE, REDCaP, Microsoft Access, Excel, and Word. This ensures accurate data collection and reporting for all research activities

Compliance and Regulatory:

The Clinical Research Coordinator completes regulatory forms, including but not limited to IRB submissions, R&D committee, and subcommittee forms, and generates reports for oversight committees. They maintain regulatory compliance by composing necessary correspondence and reporting patient serious adverse events (SAEs) and adverse events (AEs). Additionally, they establish and maintain source and regulatory files for up to six clinical research projects, ensuring the accuracy and completeness of information and documentation, and do so in a timely manner for efficient retrieval.

Moreover, the coordinator ensures that all educational and training requirements for the VAPSHCS and the R&D department are current. This involves staying updated with mandatory training modules and certifications required to perform their role effectively and maintain compliance with organizational standards and protocols.

Other clinical research responsibilities:

The Clinical Research Coordinator determines patient eligibility for studies by reviewing patient medical records, conducting initial screenings, and assessing inclusion and exclusion criteria based on study protocols. This process involves detailed evaluation of patient history, current health status, and other relevant factors to ensure appropriate enrollment. Additionally, they evaluate pathology reports to gather critical information that may influence patient eligibility and study outcomes. This evaluation involves analyzing biopsy reports, lab results, and other diagnostic findings to ensure that all data aligns with the study's requirements and objectives.

The coordinator also attends weekly conferences, which provide a platform for discussing ongoing research, sharing updates on patient status, and addressing any issues or changes in study protocols.

The Clinical Research Coordinator handles human specimens, including processing blood, urine, and tissue samples according to study protocols. This may involve collecting, centrifuging, aliquoting, and accurately labeling samples. For shipping specimens, the coordinator adheres to biohazard specifications and IATA shipping guidelines. This includes packaging samples in approved containers, labeling shipments correctly, and completing all necessary documentation to ensure safe and timely delivery to designated labs or research facilities.

The Clinical Research Coordinator prepares clinic schedules, attends pre-clinic meetings, and provides patient health summaries. These tasks ensure that clinic operations run smoothly and that all relevant information is communicated effectively to the clinical team.

The Clinical Research Coordinator prepares general correspondence, reports, emails, and letters for review and signature The recipients of these communications include the study team, supervisor, Institutional Review board (IRB), Research and Development Committee (R&D) and clinical research sponsors.

Other duties include: general faxing, photocopying, equipment maintenance, document delivery, etc; other duties as required.

Position Requirements:

• Masters degree in science, health or social science field OR BA/BS and 1-4 years of experience in research coordination.

Knowledge and Experience:

• Research regulatory forms (IRB submissions, R&D committee and subcommitte forms, oversight committee reporting)
• Handling human specimens (processing blood, urine and tissue samples.
• RAVE, REDCap, Micosoft Access, Exel and Word.