The Precision OncologyClinical Research CoordinatorII(CRC)isresponsible forensuringday-to-daycoordinationof investigator-initiatedand industry sponsoredresearch studieson behalf ofthe Stuart and Molly Sloan Precision Oncology Institute at Fred Hutch.The CRC willoversee allsubject-level study workflows including screening patients for eligibility, performing enrollments, tracking patient visits, coordinating research specimen collection and submission, and creating andmaintainingresearch documentation.The CRCleadsprotocolsdesignatedas biobanking and observational, witha specific focus on strategies for targeting individualized features of patients and environments tooptimizetreatment outcomes for patients with cancer. The CRCwillbe requiredto performassignedresponsibilities witha high levelof independence within the scope of study protocol(s) and institutional policies and guidelines.

• Conduct daily clinical operations of assigned research studiesin accordance withstudy protocols, regulatory and GCP guidelines, and institutional policy.
• Develop andmaintaintools for study implementation, including data collection tools, referencematerialsand specific study orders; revise andutilizetoolsas necessary.
• Create anddisseminatestudy-related educational content for internal and external audiences to ensure safe andaccurateprotocol implementation.
• Coordinate patient enrollment and participation by reviewing study candidatesmedical records for eligibility,initiatingenrollment,facilitating theinformed consentprocess, andmaintainingaccurateenrollment records.
• Schedule patient clinic visits and on-going study visits; ensure administrative compliance with study protocols with respect to clinical procedures, laboratorytestsand other patient activities; may administer study questionnaires, ensure drug self-administration accountability withpatientsand 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 andmaintainresearch supplies.
• Identify,trackand confirm billable activities for patients; work with internal partners to obtain andsubmitbudget and billing information; mayassistin reviewing patient charges to ensure billing compliance.
• Act as protocol liaison with clinical teams, patients, and providers on study related topics.
• Prepare andcoordinate monitoring visits and respond to queriesand 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 relatedliteratureandmaintainingprofessional associations.
• May travel to attend industry-sponsored investigator meetings.
• Assistwithmaintainingappropriate sourcedocumentation and/or performingcasereportform data entry.
• Other duties as assigned.

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.
• Minimum two to three yearsexperience 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 bachelors degree preferred.
• Certified Clinical Research Coordinator (CCRC) or certification as Clinical Research Professional (SOCRA).
• Minimum five years of experiencein a research environment with regulatory or human research protections.
• Previousexperience working with NIH, FDA and OHRPregulationsand medical terminology.
• Excellent organizational skills, attention to detail, ability toproblemsolveand to prioritize multiple competing tasks in a dynamic environment.
• Collaborative focus is essential, as well asexcellentwritten and verbal communication skills, including computer skills.
• Ability to work with multiple data managementsystemsincluding generating reports and sourcing data from systems.
• Ability to extract data from medical records.
• Ability to apply judgement in interpreting regulations,determiningimpacts, and knowing when to escalate questions and concerns whenappropriate.

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).