Clinical Research Coordinator II

Fred Hutchinson Cancer Center•Seattle, WA

4d•Onsite

About The Position

The Clinical Research Coordinator ensures the administrative and day-to-day operations of investigator-initiated and industry-sponsored human-subjects clinical protocols and trials are completed in a timely and compliant manner. Working under limited supervision of the Principal Investigator, Clinical Research Nurse, or Clinical Research Manager, the coordinator performs responsibilities with a high level of independence within the scope of study protocols and institutional policies and guidelines. This is an onsite position. The role supports clinical research operations, participant enrollment and visits, regulatory submissions, clinical data and documentation, study monitoring, and coordination with patients, providers, and clinical teams. The coordinator may travel to industry-sponsored investigator meetings.

Requirements

High school diploma or equivalent.
Two to three years of experience in a clinical research or cancer registry environment involving regulatory or human research protections.
Knowledge of clinical trial records and procedures, and computerized data processing systems.
Demonstrated knowledge of how to synthesize study conduct.

Nice To Haves

Bachelor’s degree.
Certified Clinical Research Coordinator (CCRC) or Clinical Research Professional certification (SOCRA).
Five or more years of experience in a research environment involving regulatory or human research protections.
Previous experience with NIH, FDA, and OHRP regulations and medical terminology.
Excellent organizational skills, attention to detail, problem-solving ability, and ability to prioritize multiple competing tasks in a dynamic environment.
Collaborative focus and 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 judgment in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns.

Responsibilities

Conduct daily clinical operations for assigned research studies in accordance with study protocols, regulatory and GCP guidelines, and institutional policy.
Develop and maintain study implementation tools, including data collection tools, reference materials, and study orders; revise and use them as necessary.
Create and disseminate study-related educational content for internal and external audiences to support safe and accurate protocol implementation.
Coordinate patient enrollment and participation by reviewing medical records for eligibility, initiating enrollment, ensuring informed consent, and maintaining accurate enrollment records.
Schedule patient clinic and ongoing study visits, ensure administrative compliance with protocol requirements for clinical procedures, laboratory tests, and other patient activities, and, as applicable, administer questionnaires, ensure accountability for patient self-administration of drugs, and perform non-clinical ECGs.
Complete clinical requisition forms, assemble patient-visit kits, transport laboratory samples, ensure samples are processed and shipped according to study guidelines, and track and maintain research supplies.
Manage IRB submissions, approvals, and renewals in coordination with the PI and study staff.
Maintain highly annotated clinical databases associated with clinical protocols and trials.
Serve as a protocol liaison with clinical teams, patients, and providers on study-related topics.
Prepare and coordinate monitoring visits, respond to study monitor queries and requests, and follow up on and resolve issues.
Maintain knowledge in the field by attending 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.
Perform other duties as assigned.