Clinical Research Coordinator II - Community Sites

Fred Hutchinson Cancer Center is seeking a Clinical Research Coordinator II to coordinate Phase I–III interventional clinical trials and observational Cancer Control studies across community-based oncology sites. The role manages participant activities, protocol visits, study data and specimens, and regulatory documentation while supporting compliant study implementation and participant engagement.

Responsibilities

Conduct daily clinical operations of assigned research studies in accordance with study protocols, GCP, regulatory requirements, and institutional policies

Support study startup and site activation activities, including collection of regulatory documentation, completion of study-specific training, implementation of study workflows, and preparation for site initiation activities

Develop, maintain, and utilize study implementation tools, including data collection forms, study reference materials, visit guides, and workflow documents

Provide study-specific education and training to clinic staff, participants, and other stakeholders to support accurate and compliant protocol implementation

Coordinate patient enrollment and participation by identifying potential study participants, reviewing medical records for eligibility, facilitating informed consent, and maintaining accurate enrollment records

Support participant recruitment and retention activities, including participant outreach, education, and engagement strategies designed to promote study participation and completion

Schedule and coordinate participant visits in accordance with protocol requirements and study timelines

Ensure completion of protocol-required procedures, laboratory testing, questionnaires, investigational product accountability activities, and other study-related assessments as permitted by training and scope of practice

Complete clinical requisition forms, assemble visit-specific kits, process and ship research specimens according to protocol requirements, and maintain study supply inventories

Ensure timely, accurate, and complete source documentation, data entry, query resolution, and maintenance of study records in accordance with protocol and regulatory requirements

Identify, track, and confirm billable study-related activities; collaborate with internal partners to support budget development, billing processes, and compliance reviews

Serve as the primary study contact and protocol liaison for participants, providers, sponsors, clinical staff, and research teams

Collaborate with community-based providers, clinic staff, pharmacy, laboratory, imaging, and ancillary departments to ensure successful protocol implementation and participant care

Prepare for and coordinate sponsor monitoring visits; respond to monitor requests, resolve data queries, and address follow-up items in a timely manner

Identify, communicate, and appropriately escalate protocol, operational, participant safety, or compliance issues to research and clinical leadership

Maintain current knowledge of clinical research regulations, GCP, protocol requirements, and research best practices through ongoing professional development activities

May travel between community site locations to support study operations, research coverage, specimen management, training activities, and departmental meetings

Perform other duties as assigned

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

Five years of experience in a research environment with regulatory or human research protections.

Associate's Degree

Bachelor's Degree

CCRC Certification

SOCRA Certification

Research Environment Experience

Regulatory Compliance

NIH Regulations

FDA Regulations

OHRP Regulations

Medical Terminology

Data Management Systems

Report Generation

Data Sourcing

Medical Record Data Extraction

Regulatory Interpretation

Impact Assessment

Escalation of Concerns

Organizational Skills

Attention to Detail

Problem-Solving

Prioritization

Written Communication

Verbal Communication

Professional Judgment

Benefits

Medical/vision

Dental

Flexible spending accounts

Life

Disability

Retirement

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)

Company

Nonprofit cancer center and UW Medicine cancer program

Seattle, Washington, USA

http://www.fredhutch.org/

Founded in 1975

1001-5000 employees

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

Knowledge of clinical trials records, procedures, and computerized data processing systems

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)

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

Minimum two to three years’ experience in a clinical research or cancer registry environment with regulatory or human research protections.

Required skills

Clinical Research, Cancer Registry, Human Research Protections, Clinical Research Coordinator (CCRC) Certification, SOCRA Clinical Research Professional Certification, NIH Regulations, FDA Regulations, OHRP Regulations, Medical Terminology, Medical Record Data Extraction

Preferred skills

Associate or bachelor's degree preferred

Experience

2-3 years