Responsible for establishing an integrated IIT Program Office that provides protocol development, data management, startup & amendment related processes for IITs from initiation to closeout.
Directly oversee a team comprising Protocol Writers, Project Managers, and EDC Design Leads, and project-manage the work of various specialists engaged in study startup (Regulatory, Financial, Clinic, Lab, etc.); remain accountable for projects end-to-end.
Responsible for ensuring study protocol and other required minimum documentation are complete, vetted with all relevant stakeholders, and aligned prior to study entering startup.
Oversee protocol writers and actively manage or coordinate with staff who are engaged in development of protocol and ancillary documents (manuals, patient facing documents) through an iterative development process until final signoff by Investigator.
Facilitate financial, clinic feasibility completion and alignment with protocol documents prior to studies entering startup.
Establish and implement requirements and expectations for stakeholder inputs and reviews, including biostatistics, Community Outreach and Engagement, and applicable internal resources such as manufacturing and specialty labs.
Engage central Regulatory Affairs Specialists when an IND submission is required and ensure project plan accounts for FDA timelines.
Manage timelines related to each activity and manage PI expectations and deliverables.
Oversee the development and maintenance of guidelines, Standard Operating Procedures (SOPs), workflows, and templates to support related to protocol development and data capture & management activities for IITs.
Maintain protocol templates for treatment trials, interventional non-treatment trials, and non-interventional studies; ensuring appropriate stakeholder review and communications prior to release.
Oversee authoring and maintaining of data-related documents including, but not limited to: eCRFs, eCRF Completion Guidelines, and Data Management Plans.
Identify and implement systems to support efficient and quality IIT protocol and database development and management.
Stay current on electronic solutions, assess and recommend solutions including EDC platforms and AI tools.
Develop and manage processes and systems to assess protocol design and data quality throughout study lifecycle.
Responsible for facilitating debriefs on first patient enrolled, logging gaps identified during trial management and driving updates to study via structured implementation of study amendments.
Ensure data quality; oversee data quality control (QC) processes and query resolution.
Recommend, draft, and implement institution-wide policy regarding IIT protocol development and data management requirements.
Perform other related duties as assigned.
QualificationsREQUIRED QUALIFICATIONS
Bachelor’s degree required or equivalent experience.
Minimum three years of staff management experience and five years of experience in clinical trial/protocol management.
Demonstrated knowledge of clinical research operations and current regulations related to FDA, INDs, IDEs, Human Subjects, and Good Clinical Practice.
Strong prioritization, communication, and clinical interpretive skills.
Proven ability to develop effective, collaborative relationships at all levels.
Willing to train and mentor junior study staff
PREFERRED QUALIFICATIONS:
Experience managing invesitigator-initiated trials protocol development including hands-on experience writing clinical research protocols.
Sustained, proven ability to think analytically, problem solve and use independent judgment.
Excellent communication (written and oral), customer service, collaboration, problem solving and interpersonal skills.
Excellent interpersonal skills with the ability to build strong relationships with a diverse group of stakeholders, including technical and non-technical personnel at various levels in the organization.
Knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations.
Knowledge of CTMS and EDC systems.
Knowledge of EHR systems.
Excellent computer skills including ability to use wide variety of software packages for research data management.
The annual base salary range for this position is from $139,464 to $232,419, and pay offered will be based on experience and qualifications.This position may be eligible for relocation assistance.This position may be eligible for sign on bonus.Fred Hutchinson Cancer Center offers employees a designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).Additional InformationWe are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. 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 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 Human Resources at hrops@fredhutch.org or by calling 206-667-4700.
