Clinical Research Coordinator I

Overview

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 I helps to organize and carry out day-to-day operations and administrative functions of hematopoietic cell transplantation observational studies with a focus on survivorship. 

Responsible for screening patients for eligibility, tracking patient visits, coordinating clinic procedures, and the collection, abstracting, reporting, and quality control of study data in accordance with IRB-approved protocols.  Responsible for coordination of studies and the long-term follow-up activities associated with these protocols.

This individual will work under the general supervision of the Principal Investigators of the studies and will be required to perform his/her responsibilities with a high degree of independence within the scope of study protocol(s) and institutional policies and guidelines.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

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

In order to be considered for this role, a Cover Letter is required with your application.

Responsibilities

Principal Investigator Support:

• 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.
• Assist the Principal Investigator (PI) with scheduling and taking minutes during conference calls and creating reports.

Protocol Implementation:

• Abstract charts to collect study data. Enter data into study databases
• 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 study.
• Initiate scheduling of patient clinic visits, and on-going study visits. Ensure clinical procedures, lab tests, 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.

Enrollment:

• Screen potential subjects’ medical records for study eligibility
• Meet with patients to discuss studies and obtain informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.

Education:

• Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.

Budget & Billing:

• Understand clinical trial budget and billing plans for patients enrolled on clinical trials.
• Work with internal partners to obtain and submit budget and billing information.
• Participate in the review of charges for patients on studies to ensure billing compliance.

Other Duties Which May Be Required:

• Administer study questionnaires.
• Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies. 
• Maintain or assist in maintaining IRB correspondence and regulatory documentation.  Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, and other study reports.
• 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.
• Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.

SCOPE OF RESPONSIBILITY: 

This individual will work under the supervision of the Principal Investigators, will report regularly to the PIs about study progress, and will be required to perform his/her responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. Uses judgment in data collection, quality control, liaison, and research coordination activities. Interacts with patients, physicians, and other clinical providers and support staff within and outside of the Fred Hutch/University of Washington system including the Transplant Clinical Service. 

Qualifications

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:

• Bachelor’s degree in life sciences
• Minimum of one to two years of clinical research or related experience
• Previous experience in oncology research and clinical data collection
• 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.
• Two years of experience in a research environment with regulatory or human research protections. 
• Knowledge of clinical trials records, procedures, and computerized data processing systems.
• Familiarity with medical terminology and ability to extract data from medical records.

In order to be considered for this role, a Cover Letter is required with your application.

The hourly pay range for this position is from $27.01 to $38.45 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).

Additional InformationWe 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 [email protected] or by calling 206-667-4700.