Clinical Research Coordinator II

at  Fred Hutchinson Cancer Center

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.
The Clinical Research Coordinator II is responsible for the day-to-day coordination of Oncology clinical trials. The role is an integral part of our rapidly expanding central Clinical Trial Coordination team within the Fred Hutch and Fred Hutch/University of Washington Cancer Consortium’s clinical trials office, Clinical Research Support (CRS). Reporting to the Senior Manager of Clinical Trials Coordination, the position will support our Breast Oncology, Gastrointestinal Cancer, Genitourinary Medical Oncology or other specialized Oncology clinical research portfolios.
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.

Responsibilities:

• Provides day-to-day coordination of oncology clinical research studies within Fred Hutch and UW clinic setting including, screening patients for protocol eligibility, ensuring informed consent has been properly obtained, enrolling subjects, collecting data and communicating with clinic staff
• Collaborates with clinic providers and staff, ancillary services, and research staff regarding protocol implementation and operations.
• Coordinates research protocol monitoring and auditing visits and takes action to correct problems such as deviation from protocol requirements to ensure research quality.
• Initiate scheduling of participant clinic visits and on-going study visits. As needed, attend participant visits and ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols
• As needed, 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
• Serve as liaison for Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study participant
• Respond to data queries and other requests from data coordinators and study monitors in a timely manner
• Document study related activity in the Epic EHR system, eReg, CTMS and other systems as applicable
• As needed, identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy
• Provide back-up for other Clinical Research Coordinators as needed. Provide back up for Data Coordinator on applicable trials
• Other duties as assigned.

Qualifications:

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.
• 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.

PREFERRED QUALIFICATIONS:

• Associate or bachelor’s degree in related field
• Previous experience in oncology research
• CCRP or CCRC accreditation
• Experience working with electronic medical records (EMR) and a clinical trial management system (CTMS)
• Proficiency with email, spreadsheets, word processing, and databases.
• Ability to understand and follow multiple complex protocols at multiple sites.
• Ability to develop and/or present content to senior leaders and other groups.
  A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.
  The hourly pay range for this position is from $30.30 to $45.43 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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).
  Our Commitment to Diversity: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. 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 are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and 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

• Provides day-to-day coordination of oncology clinical research studies within Fred Hutch and UW clinic setting including, screening patients for protocol eligibility, ensuring informed consent has been properly obtained, enrolling subjects, collecting data and communicating with clinic staff
• Collaborates with clinic providers and staff, ancillary services, and research staff regarding protocol implementation and operations.
• Coordinates research protocol monitoring and auditing visits and takes action to correct problems such as deviation from protocol requirements to ensure research quality.
• Initiate scheduling of participant clinic visits and on-going study visits. As needed, attend participant visits and ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols
• As needed, 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
• Serve as liaison for Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study participant
• Respond to data queries and other requests from data coordinators and study monitors in a timely manner
• Document study related activity in the Epic EHR system, eReg, CTMS and other systems as applicable
• As needed, identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy
• Provide back-up for other Clinical Research Coordinators as needed. Provide back up for Data Coordinator on applicable trials
• Other duties as assigned