Sr Clinical Research Operations Specialist
Sr Clinical Research Operations Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Overview
Fred Hutchinson Cancer Center is an independent nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle Fred Hutch is the only National Cancer Institutedesignated cancer center in Washington.
With a track record of global leadership in bone marrow transplantation HIV/AIDS prevention immunotherapy and COVID19 vaccines Fred Hutch has earned a reputation as one of the worlds leading cancer infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology infusion radiation proton therapy and related services and network affiliations with hospitals in five states. Together our fully integrated research and clinical care teams seek to discover new cures to the worlds deadliest diseases and make life beyond cancer a reality.
At Fred Hutch we value collaboration compassion determination excellence innovation integrity and respect. Our mission is directly tied to the humanity dignity and inherent value of each employee patient community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.
We are actively expanding our central research teams to support Principal Investigators (PIs) and study teams who are focused on missioncritical clinical trials programs. TheSr. Clinical Research Operations Specialistwill be primarily responsible for project managing clinic implementation activities to help ensure all clinical trial implementation gaps and issues for a study are identified and addressed in a timely manner until the trial is open to enrollment and then subsequently project manage clinical trial implementation of amendments through the life cycle of the study. The role is a key member of the Clinical Readiness Team within the Fred Hutch Clinical Research Support Department and actively collaborates with Clinical Trial Nurses pharmacists clinical service areas and research teams in driving implementation activities. This is a highgrowth opportunity that allows for learning & impact in a variety of dimensions including cutting edge clinical trial operations process improvement technology tools and datadriven decision making.
Responsibilities
- Track & manage a portfolio of 20 clinical trials.
- Set goals and timetables for each trial submitted to the Clinic Readiness team ensuring that all clinic implementation activities related to study startup are completed.
- Using standard tools & templates maintain and track detailed project plan & issues tracker for clinic implementation activities from presubmission support to open to accrual; Subsequently support clinic implementation project management of amendments through the lifecycle of a study.
- Anticipate issues & barriers to study implementation and lead proactive steps to resolve issues & barriers.
- Lead multidisciplinary project teams interacting with many different levels of staff within Clinical Research Support & other departments at Fred Hutch & UW
- Effectively use written and oral communication skills. This includes exceptional note taking maintaining clear concise project management documents.
- Serve as study liaison representing the study to other Center departments from a clinic implementation perspective. Give presentations as necessary.
- Analyze and apply expertise related multiple complex clinical trial protocols & associated documents.
- Draw out key information to help identify how research will be integrated into clinic activities.
- Call out areas and influence solutions where additional operational workflow/training are needed to accommodate protocol activities and identify implementation barriers.
- Troubleshoot any areas where documents are inconsistent or require additional clarification and define pathways to resolution.
- Serve as subject matter expert on operational practices at Fred Hutch and UW to help identify where specific protocols may not adhere to standard operating practices and require additional process analysis before they can be implemented.
- Lead stakeholder meetings prepping agendas and preread materials collecting & synthesizing inputs guiding discussions in a solutionoriented way documenting minutes and following up on action items.
- Provide timely & accurate updates on status to customers and leadership.
- Organize and manage time and tasks independently.
- Continually advocate identify & lead process improvement efforts
- Work with a variety of systems and tools including project management tools such as Smartsheet ticketing systems such as Zendesk Microsoft Office 365 tools actively work to enhance how systems can be used to make processes more efficient & accurate.
- Develop and/or present metrics status updates and escalations to senior leaders and other groups.
Qualifications
- Bachelors degree required; ideally in science technology or related field
- 3 years of health care operations experience preferably in clinical research
- Demonstrated ability to deliver outcomes in fast paced environments.
- Demonstrated ability to work as an effective member of an interdisciplinary team.
- Demonstrated skills in critical thinking and problem solving
- Ability to process complex documents and extract key information.
- Strong written and verbal communication skills
- Excellent attention to detail
- Customer service oriented
Preferred
- 3 years of clinical research experience
- Project Management experience
- Experience with Zendesk or other customer service software
- Certified Clinical Research Coordinator (ACRP) Certified Clinical Research Professional (SOCRA) or equivalent certification preferred.
- Oncology research experience
- Experience with Clinical Trials Management System (i.e. OnCore Velos etc.
The annual base salary range for this position is from $77976.00 to $107328.00 and pay offered will be based on experience and qualifications.
Additional Information
Required Experience:
Senior IC
Employment Type
Full-Time
