Clinical Research Coordinator I - GI

$55,078 - $78,416/Yr

Fred Hutchinson Cancer Center - Seattle, WA

Full-time - Entry Level

Seattle, WA

About the position

The Clinical Research Coordinator I at Fred Hutchinson Cancer Center plays a crucial role in the logistical management of clinical trials, ensuring compliance with study protocols and regulatory guidelines. This position is part of a central Clinical Trial Coordination team and supports specialized oncology research portfolios, contributing to the advancement of cancer treatment and research.

Responsibilities

• Coordinate and assist in carrying out daily clinical operations of assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
• Assist in disseminating study-related educational content for internal and external audiences to ensure safe and accurate protocol implementation.
• Assist with 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 ongoing 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.
• Assist in preparing for and coordinating monitoring visits and assist in responding to queries and other requests from study monitors.
• 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.
• May assist with maintaining appropriate source documentation and/or performing case report form data entry.
• Other duties as assigned.

Requirements

• High school diploma or equivalent.
• Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
• Demonstrated knowledge of how to synthesize study conduct.
• Ability to apply judgment in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
• 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.

Nice-to-haves

• Associate or bachelor's degree.
• Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
• Two 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.
• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Ability to extract data from medical records.

Benefits

• Medical/Vision insurance
• Dental insurance
• Flexible spending accounts
• Life insurance
• Disability insurance
• Retirement plan
• Family life support
• Employee assistance program
• Onsite health clinic
• Tuition reimbursement
• Paid vacation (12-22 days per year)
• Paid sick leave (12-25 days per year)
• Paid holidays (13 days per year)
• Paid parental leave (up to 4 weeks)
• Partially paid sabbatical leave (up to 6 months)