Clinical Research Coordinator II

Responsibilities

• Conduct daily clinical operations of assigned research studies in accordance with study protocols, GCP guidelines, applicable regulatory requirements and institutional policies.
• Cover eligibility review, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
• Schedule patient clinic visits and on-going study visits; ensure compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities; may administer study questionnaires and ensure drug self-administration accountability with patients.
• Complete clinical requisition forms as instructed, assemble kits for patient visits, transport laboratory samples and ensure samples are processed and shipped according to study guidelines; track and maintain research supplies.
• Identify, track and confirm billable activities for patients; work with internal finance team to assist in reviewing clinic charges to ensure billing compliance.
• Act as protocol liaison with clinical teams, patients, and providers on study related topics.
• Prepare and coordinate monitoring visits and respond to queries and other requests from study monitors, following up with and resolving any issues that may arise.
• Aid in maintaining appropriate source documentation and/or performing case report form (CRF) data entry.
• Travel from South Lake Union campus on shuttle to UW Medical Center (UWMC) Montlake to coordinate patient visits and collection of research specimens for processing and shipping.

Qualifications

• High school diploma or equivalent.
• Minimum two to three years’ experience in a clinical research or cancer registry environment with regulatory or human research protections.
• Demonstrated knowledge of how to synthesize study conduct.
• Associate or bachelor’s degree preferred.
• Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
• Minimum five years of experience in a research environment with regulatory or human research protections.
• Previous experience working with NIH, FDA and OHRP regulations and medical terminology.
• Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment.
• Collaborative focus is essential, as well as strong written and verbal communication skills, including computer skills.
• Ability to work with multiple data management systems including generating reports and sourcing data from systems.
• Ability to extract data from medical records.
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.