Clinical Research Coord I

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

The Clinical Research Coordinator is responsible for day-to-day coordination of intervention Phase I-III clinical trials of limited complexity. The position will perform tasks relating to the start-up, management and close-out of studies including: preparing IRB documentation, maintaining study records, screening patients for eligibility, tracking patient visits, and abstracting and reporting data. In some cases study start-up will be the responsibility of the Clinical Research Manager. The Coordinator will work on multiple studies for one or more investigators, and regularly update those investigators on the progress of the studies. The CRC I reports directly to the Clinical Research Manager.

- Prepares study start-up documentation including IRB documents, eligibility checklists, study-specific clinic orders and study calendars (if not completed by the Clinical Research Manager)
- Screens and registers patients; ensures eligibility requirements are met
- Assures consent forms are completed correctly and in entirety and that the consent process is appropriately documented
- Schedules study related clinic procedures such as blood draws, infusions and leukapheresis according to protocol requirements; coordinates with clinic and pharmacy staff to ensure proper documentation and timing of research-related procedures
- Attends clinic visits as time permits and when appropriate to update concomitant medications and adverse events
- Manages Serious Adverse Event reporting to study sponsors
- Manages the collection of medical records from outside local health care clinic/hospital facilities for Follow-up data
- Maintains adherence to research protocols and protocol deviation documentation
- Requests insurance authorization and assures the process is complete prior to initiation of study procedures
- Abstracts data from medical records to complete study-specific CRFs (electronic and/or paper) in timely and accurate manner; maintains shadow chart with source documents; anticipates and plans for data deadlines
- Maintains study databases and demonstrates knowledge of database definitions
- Collaborates with study sponsor/consortium delegate to assist with study monitoring/auditing visits and responds to findings
- Creates and maintains patient tracking tools; communicates status to investigators, management and relevant departments
- Manages study documentation throughout study life cycle including IRB annual renewals, modifications, serious adverse event reporting and third party safety reports, patient study charts and regulatory binder
- Liaises with study sponsor, investigator(s), subjects and members of the study team to communicate timelines, expectations and study status
- Acts as a resource to physicians, investigators, other staff members, and other organizations regarding protocol procedures, data collection requirements and other study related operations
- Maintains Patient Tracking System (PATS) and provides information for center-wide accrual reporting
- Links study participants into EPIC system for billing compliance; maintains study financial trackers
- Keeps knowledge and skills current by completing mandated training and attending meetings with the study team and the Consortium, such as the monthly coordinator meeting, relevant brown bags, faculty and administrative presentations, and other opportunities of interest

- 2+ years experience in clinical trial or related management.
- BA/BS or equivalent education.
- Attention to detail, ability to prioritize, excellent organizational skills.
- Ability to communicate effectively with a widely disparate audience.
- Ability to work independently as well as collaboratively.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2218437-2647-7321

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