Clinical Research Coordinator II - Phase 1

Fred Hutchinson Cancer Center is hiring a Clinical Research Coordinator II for its Phase 1 Clinical Trials Program. The role coordinates day-to-day interventional Phase I trials, including participant workflows, study documentation and data, research specimens, and collaboration with clinical and data coordination teams.

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

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 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, perform non-clinical ECGs, and support investigational product accountability activities, including participant education, documentation, reconciliation, and pill counts for participant-managed study medications, as applicable

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

Serve as a protocol liaison with clinical teams, patients, providers, sponsors, and research staff regarding study-related activities and protocol requirements

Prepare and coordinate monitoring visits and respond to queries and other requests from study monitors, following up on and resolving any issues that may arise

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

May travel to attend industry-sponsored investigator meetings

Maintain appropriate source documentation and perform case report form data entry, ensuring timely, accurate, and complete study records in accordance with protocol and regulatory requirements

Travel from the South Lake Union campus to UW Medical Center Montlake to oversee the transit of collected research specimens for processing and shipment

Other duties as assigned

Preferred

Associate's or bachelor's degree in a healthcare, life sciences, public health, or related field

Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP/SOCRA), or equivalent certification

Experience coordinating clinical research studies, including participant enrollment, informed consent, study visits, data collection, and research documentation

Experience working with NIH, FDA, OHRP, and ICH-GCP regulations, clinical research databases, and electronic medical records

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

Healthcare

Life Sciences Education

CCRC Certification

CCRP Certification

Clinical Research Coordination

Participant Enrollment

Informed Consent

Study Visit Coordination

Data Collection

Research Documentation

NIH Regulations

FDA Regulations

OHRP Regulations

ICH-GCP

Clinical Research Databases

Electronic Medical Records

Medical Terminology

Data Management Systems

Report Generation

Data Sourcing

Medical Record Data Extraction

Regulatory Interpretation

Impact Assessment

Organizational Skills

Attention to Detail

Problem-Solving

Task Prioritization

Written Communication

Verbal Communication

Professional Judgment

Escalation Judgment

Benefits

Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

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's or bachelor's degree in a healthcare, life sciences, public health, or related field

Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP/SOCRA), or equivalent certification

Experience coordinating clinical research studies, including participant enrollment, informed consent, study visits, data collection, and research documentation

Experience working with NIH, FDA, OHRP, and ICH-GCP regulations, clinical research databases, and electronic medical records

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 Coordination, Clinical Trial Regulations, Human Research Protections, Clinical Trial Records and Procedures, CCRC Certification, CCRP Certification, SOCRA Certification, NIH Regulations, FDA Regulations, OHRP Regulations, ICH-GCP, Electronic Medical Records, Medical Terminology

Experience

2-3 years