Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.
Mallinckrodt Instiitute of Radiology seeks an experienced clinical research professional to play a key role in managing a pioneering clinical trials infrastructure developing position emission tomography (PET) and magnetic resonance imaging (MRI) methods for the study of diseases of the central nervous system, which an emphasis on Alzheimer's disease.
This is a career opportunity for research professional with experience in all aspects of clinical research management from study concept, design, assistance with grant writing, developing lab infrastructure including databases and standard operating procedures, managing all internal and external project team members for assigned projects - including CROs and data reporting and management. This position will work collaboratively with the PI/ Medical Director to identify areas of need and to work to help identify solutions and build infrastructure to help move special projects forward as well as to provide project management for complex projects. The Clinical Trials Manager is responsible for the operational planning and execution of multiple studies from protocol concept through the clinical study report, including Phase II – III global/international.
PRIMARY DUTIES AND RESPONSIBILITIES:
These responsibilities include, but are not limited to:
Collaborating with all relevant groups to develop and manage clinical project timelines This includes all internal and external partners (Trial Sponsors, Core and Project Leaders, Funding Source Officers, Administrative Operations, CROs, Performance Sites, CRL, CNDA, CCIR, Cyclotron facility, external contract partners ).
Disseminating clinical project communication to all functional groups as appropriate.
Contributing to protocol development and Clinical Operations feasibility assessments, including assistance with defining project scope, goals and deliverables.
Tracking deliverables across projects, and monitoring project progress
Assisting with grant writing, and identification of grant opportunities as needed.
Writing study protocols, amendments and administrative changes based on approved protocol synopsis.
Creating and Managing Study Case Report Forms in REDCap®.
Participating in the selection and oversight of CRO and clinical vendors/components (biomarkers, imaging, data management).
Developing and managing clinical research Standard Operating Procedures.
Training all involved research staff to new processes or procedures.
Planning and participation in investigator meetings in collaboration with all cross-functional team members.
Ensuring the training of Investigators and Core and Project Leaders, performance sites and Cores/Components on the protocol and expectations of studies.
Partnering with Administrative Operations, Investigators, Core and Project Leaders, CRO, and/or vendors for resolution of corrective actions as a result of QA audit and/or regulatory inspections.
Meeting regularly with the PI/Director and managers to identify pain points and explore potential solutions.
Implementing and managing change when necessary to meet project outputs
Collaborating with Sponsors to ensure appropriate and timely drug/tracer supply for assigned studies.
Ensuring reporting to funding sources is performed on time, contribute to writing annual and interim reports.
Minimal travel required; approximately 10%
Applicant Special Instructions:
Minimal travel required; approximately 10%
Qualified candidates should have experience in a clinical trial role in the pharmaceutical industry and possess a bachelor's degree or RN with at least five years of management experience. Master’s Degree preferred.
Should have experience with developing and managing study databases in REDCap®.
Minimum 3 years experience managing multidisciplinary studies required.
Competencies in critical thinking, problem solving, decision making, leadership, and conflict resolution are essential.
The successful candidate should demonstrate adaptability and ability to tolerate stress.
Conflict resolution experience preferred.
Bachelor’s degree in related field or equivalent level of training and experience.
Master’s degree preferred.
Minimum of 1-2 years’ experience in clinical research.
Nursing or oncology background preferred.
SOCRA or ACRP certification required within 12 months of hire and/or when eligible.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Radiology. This position is for the Medical School Campus.
The hiring range for this position is $69,930 - $90,979 annually.
-Retirement Savings Plan -22 vacation days -8 Paid Holidays -Sick Time -Tuition benefits for employee, spouse and dependent children -Free Metro Link/ Bus pass -Free Life Insurance -Health, Dental, Vision -Health Savings Accounts (HSA) -Long Term Disability Insurance -Flex Spending Plan -Other Benefits
Med School HR website (medschoolhr.wustl.edu)
Internal Applicant Instruction:
This position is grade G14.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
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