Clinical Research Coordinator II

Fred Hutch; Seattle (WA); On-site; USD 45,000 - 67,000; Full time

Benefits offered by this job

Medical/vision

Dental

Paid vacation

Paid sick leave

Paid holidays

Parental leave

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a Clinical Research Coordinator to oversee day-to-day operations of investigator-initiated and industry-sponsored trials in a compliant, timely manner.

The role works under supervision with potential travel to industry meetings. Extensive regulatory knowledge, data management, and strong communication are essential.

Qualifications

• High school diploma or equivalent is required.
• Bachelor’s degree preferred; certification in clinical research preferred.
• Experience with NIH, FDA, and OHRP regulations is a plus.

Responsibilities

• Conduct daily clinical operations of assigned studies per protocols and GCP.
• Develop tools for study implementation and education for internal/external audiences.
• Coordinate patient enrollment, consent, and eligibility reviews.
• Schedule visits and ensure protocol compliance for procedures and labs.
• Manage IRB submissions, approvals, and renewals with PI and staff.
• Maintain annotated databases and act as liaison with clinical teams and patients.

Skills

Strong written and verbal comms

Data management systems

Data extraction from medical records

Regulatory knowledge

Attention to detail

Education

Bachelor’s degree preferred

CCRC or SOCRA certification

Five+ years research experience

Job description

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 ensures all administrative and day-to-day operations of investigator-initiated and industry-sponsored human subjects clinical protocols and 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 is an onsite position.

Responsibilities

• 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.
• Manage institutional review board (IRB) submissions, approvals, and renewals in conjunction with the PI and study staff.
• Maintain highly annotated clinical databases associated with clinical protocols and trials.
• 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.

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.

PREFERRED QUALIFICATIONS:

• A bachelor’s degree is 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, 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 $32.63 to $48.93 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 Information

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 [e-mail] or by calling 206-667-4700.