What are the responsibilities and job description for the Clinical Research Coordinator II - NeuroOncology position at Fred Hutch?
https://careers-fhcrc.icims.com/jobs/27471/clinical-research-coordinator-ii---neurooncology/job
The Clinical Research Coordinator II is responsible for the day-to-day coordination of Oncology clinical trials. The role is an integral part of our rapidly expanding central Clinical Trial Coordination team within Fred Hutch and Fred Hutch/University of Washington Cancer Consortium’s clinical trials office, Clinical Research Support (CRS). Reporting to the Senior Manager of Clinical Trials Coordination, the position will support our Neuro-Oncology and other Medical Oncology clinical research portfolio.
This position will be onsite at our South Lake Union Campus with travel to UW Mediical Center - Montlake.
Responsibilities- Provides day-to-day coordination of oncology clinical research studies within Fred Hutch and UW clinic setting including, screening patients for protocol eligibility, ensuring informed consent has been properly obtained, enrolling subjects, collecting data and communicating with clinic staff.
- Collaborates with clinic providers and staff, ancillary services, and research staff regarding protocol implementation and operations.
- Coordinates research protocol monitoring and auditing visits and takes action to correct problems such as deviation from protocol requirements to ensure research quality.
- Initiate scheduling of participant clinic visits and on-going study visits. As needed, attend participant visits and ensure clinical procedures, lab tests, and other protocol specific activities are completed as outlined in the protocols.
- As needed, 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.
- Serve as liaison for Investigational Drug Services (IDS) on drug assignment, dispensation information, and maintain regular communication regarding status of study participant.
- Respond to data queries and other requests from data coordinators and study monitors in a timely manner.
- Document study related activity in the Epic EHR system, eReg, CTMS and other systems as applicable.
- As needed, identify and report adverse events in accordance with protocol, regulatory guidelines, and institutional policy.
- Provide back-up for other Clinical Research Coordinators as needed. Provide back up for Data Coordinator on applicable trials.
- Other duties as assigned.
MINIMUM QUALIFICATIONS:
- High School Diploma equivalent
- Minimum two to three years’ experience in clinical research with regulatory or human research protections
- Knowledge of FDA regulations, GCP guidelines, and other applicable regulations
- Ability to work independently and prioritize work in a dynamic environment
- Collaborative and skilled working across multidisciplinary teams including clinical teams
- Resourceful and able to solve problems, yet seek guidance when needed
- Comfortable working in clinic setting and interacting with patients
- Strong attention to detail and ability to work according to Standard Operating Procedures (SOPs)
- Exceptional interpersonal skills both in-person and on telephone calls
- Strong written and verbal communication skills
PREFERRED QUALIFICATIONS:
- Associate or bachelor’s degree in related field
- CCRP or CCRC accreditation
- Previous experience in oncology research
- Experience working with electronic medical records (EMR) and a clinical trial management system (CTMS)
