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.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Center for Clinical Studies. The position is located at the Northwest Tower. This position is for the Medical School Campus.
Position supports the conduct of complex clinical research studies by Washington University Investigators, and will be primarily responsible for evaluating and guiding the integration of technology resources to support traditional and remote modes of clinical study conduct.� This position will collaborate with other research professionals to develop standard operating procedures, training resources, and related documentation to support research teams and research administration units in managing electronic informed consent, traditional and remote data capture mechanisms, databases, regulatory compliance, clinical and data coordination activities, and 21 CFR Part 11 compliance for clinical trials. This position will be based in the Trial-CARE multicenter clinical trial support team within the Center for Clinical Studies (CCS), and will report to Trial-CARE unit leadership.� This position requires experience with clinical trials, including multicenter trials, and the ability to plan, execute, and troubleshoot issues related to clinical research technology, data management, and study coordination.
PRIMARY DUTIES AND RESPONSIBILITIES:
Contributes to the development, validation, and management of clinical study databases and trial-relevant technology resources, which may include vended platforms and self-service data management tools.
Develops data management plans and standard operating procedures to support a professional-quality operating structure around mobile health research, e-consent, and coordinating center activities for clinical trials, including compliance with regulatory requirements such as 21 CFR Part 11.
Serves as a resource to clinical research staff and faculty conducting multi-site clinical studies, including strategic, regulatory, and implementation guidance.
Performs study coordinator functions, including case report form development, data validation/verification, and data quality control for clinical studies.
Researches and recommends new methods and procedures to maintain standards and improve quality in the Center for Clinical Studies.
Bachelor's of Science degree plus four years of clinical or research experience with at least one year of lead or supervisory experience included; eight years of relevant education and work experience may substitute for this requirement.
Ability to organize and follow complex and/or detailed technical procedures and communicate those concepts to research staff with less experience.
Ability to work independently and perform job with minimal supervision.
Ability to manage multiple complex projects simultaneously.
Strong customer service sensibility.
Strong experience in interacting with typical clinical trial stakeholders, including investigators, research staff, biostatisticians, data coordinators, and others.
Experience in evaluating, validating, and utilizing contemporary database platforms for clinical research studies, and in participating in study coordinating centers.
Experience with developing data management plans and data sharing arrangements for studies and institutions, including familiarity with regulatory requirements & challenges.
Effective analytical and problem-solving skills.
Ability to communicate in oral and written form with all levels of personnel.
Ability to prioritize tasks in a diverse environment.
Demonstrated leadership and interpersonal skills.
The hiring range for this position is $62,067 - $79,144 annually.
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
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.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.