Clinical Research Coordinator II

Fred Hutchinson Cancer Center•Seattle, WA

25d•$32 - $48

About The Position

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington. With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality. At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. The Clinical Research Coordinator II is responsible for day-to-day coordination of interventional Phase I-III clinical trials and observational Cancer Control studies. The position will oversee all subject-level study workflows including screening patients for eligibility, performing enrollments, tracking patient visits, abstracting and reporting study data, coordinating research specimen collection and submission, and creating and maintaining research documentation. Collaborates with Data Coordination staff on the Clinical Research Support team. Reporting to the Senior Manager/Manager of Clinical Trials Coordination, the coordinator will be part of specialized Oncology research teams. This position is key to the smooth operation of clinical trials and advancing research efforts at Fred Hutch.

Requirements

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.
Knowledge of clinical trials records, procedures, and computerized data processing systems.
Demonstrated knowledge of how to synthesize study conduct.

Nice To Haves

Associate or bachelor’s degree preferred.
Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
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.
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 and apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.

Responsibilities

Conduct daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
Develop and maintain tools for study implementation, including data collection tools, reference materials and specific study orders; revise and utilize tools as necessary.
Create and disseminate study-related educational content for internal and external audiences to ensure safe and accurate protocol implementation.
Coordinate patient enrollment and participation by reviewing study candidates’ medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
Schedule patient clinic visits and on-going study visits; ensure administrative compliance with study protocols with respect to clinical procedures, laboratory tests and other patient activities; may administer study questionnaires, ensure drug self-administration accountability with patients and perform non-clinical ECGs.
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 partners to obtain and submit budget and billing information; may assist in reviewing patient 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.
Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature and maintaining professional associations.
May travel to attend industry-sponsored investigator meetings.
Assist with maintaining appropriate source documentation and/or performing case report form data entry.
Travels from South Lake Union campus on shuttle to UW Medical Center Montlake to oversee transit of collected research specimens to South Lake Union for processing and shipping
Other duties as assigned