Clinical Research Coordinator I/II

Fred Hutchinson Cancer Center•Seattle, WA

5d•Hybrid

About The Position

Fred Hutchinson Cancer Center is seeking a Clinical Research Coordinator I/II to work on studies involving children and adults who have had or will receive treatment for cancer and non-malignant hematologic diseases. The position will involve direct interaction with adults and children diagnosed with cancer and other serious diseases. This position will coordinate all protocol-required activities for study participants and is responsible for the collection and reporting of all study data and performing complex data entry into a research database. In addition, the coordinator will be responsible for compliance with all regulatory requirements for the conduct of human subjects research. The incumbent works independently in performing job assignments. Uses judgment in data entry, quality control, liaison, and research coordination activities. Interacts with patients, physicians, and other clinical providers and support staff within the Fred Hutch/SCH system. This role will have the opportunity to work partially at our campus and remotely.

Requirements

Clinical Research Coordinator I: 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 synthesize study conduct.
Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.
Clinical Research Coordinator II: All qualifications for Clinical Research Coordinator I, plus: Minimum two to three years’ experience in a clinical research or cancer registry environment with regulatory or human research protections.
Must be a self-starter with the ability to locate resources and operate productively in an environment where standard operating procedures, guidelines and policies are not always available.
Knowledge of clinical trials records, procedures, and computerized data processing systems.

Nice To Haves

Clinical Research Coordinator I: Bachelor’s degree
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.
Flexibility with work schedule required as required in-person work will be driven by research patient visits, which will be variable.
Knowledge of clinical trials records, procedures, and computerized data processing systems.
Knowledge of medical terminology.
Ability to extract data from medical records.
Strong computer skills, including proficiency in Excel and Word, and experience working with databases.
Strong verbal and written communication skills.
Clinical Research Coordinator II: All Qualifications of Clinical Research Coordinator I, plus:
Prior role as a Clinical Research Coordinator in a hospital/clinical environment
Experience in investigator-initiated trials
Clinical research-related professional certification
Prior exposure to CTMS OnCore, Florence, and/or EDC platforms.
Previous experience with IRB or other regulatory bodies.
Prior exposure to Cancer Consortium start-up and amendment process.

Responsibilities

Screen, consent and register patients; ensure eligibility requirements are met.
Schedule study related procedures such as blood draws, imaging and clinic visits according to protocol requirements; coordinate with clinic staff to ensure proper documentation and timing of research-related procedures.
Order, track and route research specimens.
Complete study-specific CRFs (electronic and/or paper) in timely and accurate manner.
Completion of regulatory file submissions, maintaining regulatory files, and assurance of compliance with local and federal regulations.
Prepare enrollment reports.
Support regularly scheduled institutional monitoring visits to ensure quality and completeness of data.
Abstract data from patient medical charts.
Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature and maintaining professional associations.
Other related duties as assigned.