Clinical Research Coordinator I

Fred Hutchinson Cancer Center•Seattle, WA

7h•Hybrid

About The Position

The Clinical Research Coordinator helps to organize and carry out day-to-day operations and administrative functions of hematopoietic cell transplantation observational studies with a focus on survivorship. Responsible for screening patients for eligibility, tracking patient visits, coordinating clinic procedures, and the collection, abstracting, reporting, and quality control of study data in accordance with IRB-approved protocols. Responsible for coordination of studies and the long-term follow-up activities associated with these protocols. This individual will work under the general supervision of the Principal Investigators of the studies and will be required to perform his/her responsibilities with a high degree of independence within the scope of study protocol(s) and institutional policies and guidelines. 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. This role will have the opportunity to work partially at our campus and remotely. In order to be considered for this role, a Cover Letter is required with your application.

Requirements

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 synthesis study conduct.
Ability to apply judgement in interpreting regulations, determining impacts, and knowing when to escalate questions and concerns when appropriate.

Nice To Haves

Bachelor’s degree in life sciences
Minimum of one to two years of clinical research or related experience
Previous experience in oncology research and clinical data collection
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.
Two years of experience in a research environment with regulatory or human research protections.
Knowledge of clinical trials records, procedures, and computerized data processing systems.
Familiarity with medical terminology and ability to extract data from medical records.

Responsibilities

Serve as designee of the Principal Investigator (PI) to manage the daily clinical operations of assigned research studies in accordance with regulatory, GCP guidelines and institutional policy.
Assist the Principal Investigator (PI) with scheduling and taking minutes during conference calls and creating reports.
Abstract charts to collect study data.
Enter data into study databases
Develop and maintain tools for study implementation, which may include data collection tools, study reference materials, and study specific orders. Revise and utilize tools as necessary to fulfill the aims of the study.
Initiate scheduling of patient clinic visits, and on-going study visits.
Ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols.
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.
Screen potential subjects’ medical records for study eligibility
Meet with patients to discuss studies and obtain informed consent, initiate patient enrollment, and ensure accurate enrollment records are maintained.
Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation.
Understand clinical trial budget and billing plans for patients enrolled on clinical trials. Work with internal partners to obtain and submit budget and billing information. Participate in the review of charges for patients on studies to ensure billing compliance.
Administer study questionnaires.
Function as a protocol liaison with clinical teams, patients, and when necessary, other institutions or drug companies.
Maintain or assist in maintaining IRB correspondence and regulatory documentation.
Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, and other study reports.
Maintain appropriate source documentation, and complete or assist with accurate data entry into case report forms in a timely manner.
Coordinate monitoring visits and respond to queries and other requests from study monitors.
Identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.