The Clinical Research Coordinator II is responsible for day-to-day coordination of interventional Phase I-III clinical trials and observational Cancer Control studies. The position will oversee all subject-level study workflows including screening patients for eligibility, performing enrollments, tracking patient visits, abstracting and reporting study data, coordinating research specimen collection and submission, and creating and maintaining research documentation. Collaborates with Data Coordination staff on the Clinical Research Support team.

Reporting to the Research Manger of Clinical Trials Coordination, the coordinator will be part of specialized Oncology research teams, including Gastroenterology. This position is key to the smooth operation of clinical trials and advancing research efforts at Fred Hutch. 

• 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. 
• Will travel from South Lake Union campus on shuttle to UW Medical Center (UWMC) Montlake to coordinate patient visits and collection of research specimens for processing and shipping.
• Other duties as assigned.

MINIMUM 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.

PREFERRED QUALIFICATIONS:

• Associate or bachelor’s degree preferred.
• Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
• Minimum 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.
• Collaborative focus is essential, as well as 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.
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.

The hourly pay range for this position is from $31.83 to $47.73 and pay offered will be based on experience and qualifications.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.Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include 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), and paid parental leave (up to 4 weeks).