The Clinical Research Coordinator ensures all administrative and day-to-day operations of investigator-initiated and industry-sponsored human subjects clinical trials are completed in a timely and compliant manner.  This individual will work under limited supervision of the Principal Investigator, Clinical Research Nurse or Clinical Research Manager and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional policies and guidelines.

This role will have the opportunity to work partially at our campus and remotely.

• 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.
• Create and disseminate study-related educational content for internal and external audiences to ensure safe and accurate 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 on-going 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.
• 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.
• 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.
• Assist with maintaining appropriate source documentation and/or performing case report form data entry.
• 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).