Clinical Research Coordinator II - J. Hill Group
Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.
The position will work directly with an Assistant Professor in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to provide support to the Principal Investigator and research staff in the development, implementation and management of his diverse research portfolio, including research studies and clinical trials.
The Clinical Research Coordinator (CRC) will be responsible for providing support on all aspects of research study and clinical trial development and implementation. Primary responsibilities of the CRC will include assistance with the planning, coordination, implementation, and close-out (e.g. presentation of data, manuscript writing) of industry-sponsored clinical trials, in addition to retrospective and prospective observational or investigator-initiated interventional studies. Additional responsibilities will include communicating with internal and external collaborators and supporting study personnel in the preparation of regulatory documentation and audits if applicable.
Under the supervision of the Assistant Professor, the CRC will manage a portfolio of clinical research projects and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. The position will include interaction with patients, physicians, researchers, and other clinical providers and support staff within and outside of the Fred Hutch/ Seattle Cancer Care Alliance (SCCA) / UW system including the SCCA Patient Care Services.
Responsibilities
- Assist the research manager with preparing start-up documentation including IRB documents, eligibility checklists, study procedures/SOPs, study-specific clinic orders and study calendars (if not completed by the Clinical Research Manager)
- Screens and registers patients; ensures eligibility requirements are met
- Ability to consent patients and assures consent forms are completed correctly and in entirety
- Schedules study related clinic procedures such as blood draws, infusions and imaging according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures
- Perform review of medical charts using ORCA/MINDscape and enter data in REDCap, Excel or other study-related databases
- Abstracts data from medical records to complete study-specific case-report form (CRFs) (electronic and/or paper) in timely and accurate manner; maintains shadow chart with source documents
- Maintain study and specimen tracking and inventory records for biospecimens pulled from repository
- Assemble study kits for clinical trials
- Perform basic processing and banking of lab specimens and associated record keeping
- Collaborates with study sponsor/consortium delegate to assist with study monitoring 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, patient study charts and regulatory binder
- Liaises with study sponsor, investigator(s), research manager and members of 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
- 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 lectures, faculty and administrative presentations, and other opportunities of interest
- Perform other duties as assigned
Qualifications
- Bachelor’s degree in scientific/medical field or equivalent experience/education. Minimum of three years post-bachlor's experience in clinical study/trials coordination or relateed field.
- Clinical research related certification is preferred
- Experience with industry-sponsored clinical trials and documentation of case report form (eCRF) in study electronic data capture (EDC) system
- Ability to work in teams and independently, flexible hours at times in support of clinical trials and regulatory and related compliance
- Strong attention to detail and project management skills and experience is required
- Well-organized and ability to juggle numerous tasks, often with conflicting and competing deadlines
- Strong written and verbal communication skills
- Strong computer skills, including proficiency in the Office Suite, and experience working with excel and databases (preferably REDCap)
- Knowledge of federal regulations and guidelines that govern clinical research, including GCP and human subjects research
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
Our Commitment to Diversity
We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.