Clinical Research Coordinator II

Fred Hutchinson Cancer Center•Seattle, WA

9d•Hybrid

About The Position

The Clinical Research Coordinator II (CRC II) is a role on the Phase 1 Clinical Trial Program and is responsible for day-to-day management of oncology clinical trials. The position will oversee all subject-level study workflows including screening patients for eligibility, coordinating and tracking patient visits and procedures, and creating and maintaining research documentation. The position interfaces with the clinic, providers, investigators, and teams across the clinical research enterprise. At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

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 working in clinical research, preferably oncology interventional trials.
Working understanding of applicable regulations and guidelines including FDA, ICH GCP, and HHS
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, GCP guidelines, applicable regulatory requirements and institutional policies.
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 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.
Assist with maintaining appropriate source documentation and/or performing case report form (CRF) data entry.
May travel from South Lake Union campus on shuttle to UW Medical Center (UWMC) Montlake to coordinate patient visits.
Other duties as assigned.