Clinical Research Coordinator I

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

 

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

 

The Clinical Research Coordinator helps to organize and carry out day-to-day operations and administrative functions of investigator-initiated and industry-sponsored human subject clinical trials.

This individual will work under general supervision of the Clinical Program Operations Director and will be required to perform his/her responsibilities with limited degree of independence within the scope of study protocol(s) and institutional policies and guidelines.

• Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
• Review study candidates’ medical records in detail for study eligibility.
• Ensure informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
• Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
• Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders.  
• Revise and utilize tools as necessary to fulfill the aims of the clinical trial.
• Initiate scheduling of patient clinic visits, and on-going study visits.  Attend patient visits and ensure clinical procedures, lab test, and other protocol specific activities are completed as outlined in the protocols.
• Complete requisition forms, assemble kits for upcoming research visits, transport laboratory samples, and ensure samples are processed and shipped according to study specific guidelines, while tracking and maintaining research supplies.
• Collaborate with Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study subjects.
• Ensure study drug self-administration and accountability with patients, perform non-clinical ECGs, administer study questionnaires and other protocol-driven non-clinical assessments.
• Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies. 
• Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner. 
• Coordinate monitoring visits and respond to queries and other requests from study monitors.
• Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
• Understand clinical trial budget and billing plans for patients enrolled on clinical trials. Participate in the review of charges for patients on clinical trials to ensure billing compliance.
• Provide input regarding IRB correspondence and regulatory documentation. 
• Travel for industry sponsored investigator meetings.
• Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.
• Provide back up for other Clinical Trial Coordinators as needed. Provide back up for Data Coordinator on applicable trials.

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.
• Minimum one year experience in a clinical research or cancer registry environment with regulatory or human research protections.
• Demonstrated knowledge of how to synthesis study conduct.
• Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.

PREFERRED QUALIFICATIONS:

• Associate or bachelor's degree preferred.
• 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.

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The hourly pay range for this position is from $26.48 to $37.70 and pay offered will be based on experience and qualifications.

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).

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.