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Fred Hutch · 2 days ago

Clinical Research Coordinator II

Seattle, WA

Full-time

Onsite

Entry, Mid Level

$31.83/hr - $47.73/hr

2+ years exp

Fred Hutchinson Cancer Center is an independent, nonprofit organization focused on groundbreaking research and treatment of cancer and infectious diseases. The Clinical Research Coordinator II will oversee day-to-day operations of clinical trials and ensure compliance with protocols while collaborating with various teams to advance research efforts.

Hospital & Health Care

No H1B

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

Qualification

Clinical research experienceClinical trialsRegulatory compliance knowledgeCertified Clinical Research CoordinatorData management systemsOrganizational skillsAttention to detailProblem-solving skillsCommunication skills

Required

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

Preferred

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