Clinical Research Coordinator I --Infectious Disease Sciences
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 incumbent will participate in the planning, coordination, and implementation of complex investigator-initiated, industry-sponsored, and cooperative group clinical research studies involving human subjects in the Infectious Disease Sciences Program. This individual will work with a diverse team, but have a high level of independence within the scope of study protocol(s) and institutional guidelines. The team member will have patient facing responsibilities and participate in both investigator initiated and pharmaceutical industry trials among cancer patients. Collaborative skills are a must and experience with clinical trials desired.
Responsibilities
Study Conduct / Clinical Research Practice
- Work independently in performing daily responsibilities required to plan and execute investigator driven/industry-based clinical research trials and non-intervention protocols
- Coordinate research and administrative activities related to studies, ensuring all projects are completed according to project timelines
- Serve as project liaison, representing the project to other center departments, funding sources, affiliated individuals or institutions, and outside organizations
- On assigned projects, act as the main protocol resource person for the investigator and/or research sponsor, research subjects, local and central labs, monitors, primary care teams, and investigational pharmacy staff
- Collaborate with investigators and coworkers to ensure completion of study activities
- Train others as needed and develop standard operating procedures (SOP) or other necessary documents for standardized study conduct
- Screen and recruit subjects either within the consortium or the community dependent upon study specific requirements, enroll, and follow research subjects, complete case report forms (CRFs), place physician orders, coordinate research study visits, communicate with the primary care teams, investigational pharmacy staff and research subjects
- Ensure accurate enrollment records are maintained and up to date
- Coordinate specimen collection, transport, processing, storage, and shipment procedures according to protocol requirements. Track and maintain research supplies.
- Create source documents or CRFs as needed to promote efficient data collection and entry
- Review CRFs to ensure completeness, accuracy, and compliance with Good Clinical Practice
- Identify and report any adverse events in accordance with protocol, regulatory guidelines, and institutional policy
- Manage the production of study kits
Protocol Development and Implementation
- Help develop and review research protocols for feasibility and collaborate with study leadership to develop the study budget and implementation plans
- 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 clinical trial.
Budget and Billing
- Prepare requests for research prices on study activities and coordinate the research billing start-up process
- Review, reconcile, and approve research study bills. Work closely with the IDS fiscal staff to ensure accurate research billing and reimbursement
Regulatory Compliance and Documentation
- Facilitate protocol monitoring visits and collaborate with study monitors to resolve data discrepancies and procedural issues
- Provide input to the regulatory coordinator on protocol document submissions and continuing review reports
- Prepare or assist in preparing consent forms, continuation review reports, protocol modifications, serious adverse event reports, and other study reports
Other Duties Which May Be Required:
- Perform retrospective chart review as required
- Travel for investigator meetings
- May require weekends and holiday coverage for clinical studies
- Other duties as assigned
Qualifications
- BA/BS in a life sciences field of study required
- Applicant must have at least one year of research or related experience
- 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
- Experience in clinical trials coordination setting
- Computer experience including electronic CRF, MS Office including Excel, Outlook, PowerPoint, and Access
- Excellent written and communication skills, attention to detail, high-level organization, leadership ability, and the flexibility to work in collaboration with a multi-disciplinary team
- Previous experience in oncology research and clinical data collection is preferred
- Prior experience with EPIC is desirable
- Knowledge using REDCap databases is desirable
- Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent certification is preferred
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.