Clinical Research Coordinator I - 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
- Prepares study start-up documentation including FDA submissions, eligibility checklists, study-specific clinic orders and study calendars
- Research, maintain, analyze, and abstract patient clinical trial data from pre-study background (e.g., previous diagnoses and treatments) through clinical trial participation and long-term follow-up
- Ensures patient eligibility requirements for clinical trials are met, assists in patient enrollment, screens and registers patients on study
- Understand and interact with departments and automated electronic medical record systems throughout Fred Hutch/SCCA/UW system to ensure timely and complete delivery of data
- Track status of potential and active clinical trial participants
- Create and maintain the study’s manual of operations and laboratory manual
- Create and maintain a REDCap database or equivalent for collection of study data. Abstracts data from medical records to complete study-specific case report forms. Maintains shadow chart with source documents. Assists in the development of data acquisition forms and instructions for completion.
- Schedules study related clinic procedures such as blood draws, infusions and treatment according to protocol requirements; coordinates with clinic staff to ensure proper documentation and timing of research-related procedures
- Coordinate and support regularly scheduled Sponsor or institutional monitoring visits to ensure quality and completeness of data. Responds to all findings and implements corrective action as necessary.
- Coordinate long-term follow-up evaluations and data collection with clinical trial participants, SCCA, and participants’ local physicians
- Serve as a liaison and reference resource to Physicians, Investigators, other staff members, and other organizations with questions about data collection or protocol procedures and requirements
- Coordinate special projects regarding data collection, analysis, output, and presentation
- Ensures compliance with ongoing reporting requirements to the Food and Drug Administration, National Institutes of Health, Human Subjects Committee, Institutional Review Board, Pharmaceutical Companies, and other agencies, to include annual reports, study amendments, safety reports, and unanticipated problem/noncompliance reports
Qualifications
- BA/BS in a life sciences field of study required
- Applicant must have one to two years of research or related experience
- Previous experience in oncology research and clinical data collection is preferred
- This position requires 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
- Ability to work in teams and independently, flexible hours at times in support of clinical trials and regulatory and related compliance
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.