Clinical Research Coordinator II

Fred Hutchinson Cancer Center•Seattle, WA

About The Position

The Precision Oncology Clinical Research Coordinator II (CRC) is responsible for ensuring day-to-day coordination of investigator-initiated and industry sponsored research studies on behalf of the Stuart and Molly Sloan Precision Oncology Institute at Fred Hutch. The CRC will oversee all subject-level study workflows including screening patients for eligibility, performing enrollments, tracking patient visits, coordinating research specimen collection and submission, and creating and maintaining research documentation. The CRC leads protocols designated as biobanking and observational, with a specific focus on strategies for targeting individualized features of patients and environments to optimize treatment outcomes for patients with cancer. The CRC will be required to perform assigned responsibilities with a high level of independence within the scope of study protocol(s) and institutional policies and guidelines.

Requirements

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.

Nice To Haves

Associate or bachelor’s degree 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 is essential, as well as excellent 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.

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, facilitating the informed consent process, 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.
Identify, track and confirm billable activities for patients; work with internal partners to obtain and submit budget and billing information; may assist in reviewing patient charges to ensure billing compliance.
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.