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Under administrative review, performs management level work directed toward the planning, development, implementation, and evaluation of a multi-center study or multiple large studies. Requires the use of judgment and discretion in performing the assigned duties and responsibilities related to the project. These actions tend to establish precedents and direction for the project(s).
Job Responsibility:
Oversees the operational activities at the clinical site(s) and coordinates the activities of a multi-center study or multiple large studies
Collaborates with principal investigator(s) in developing plans for research projects and to discuss the interpretation of results
Negotiates protocol changes with funding agency/sponsor
Assumes major responsibility for the successful and timely completion of the tasks that comprise the implementation and analysis phases of a multi-center study or multiple studies including planning, development, implementation, and evaluation
Coordinates the hiring of and provides direction to support staff
Plans and coordinates training sessions for project personnel located at the different clinical sites
Oversees recruitment, data collection, and follow-up activities
Translates planning and design decisions into concrete activities and tasks for project implementation, and sets priorities for project implementation
Evaluates and interprets collected clinical data
Manages the preparation of progress reports and quality control monitoring
participate in the analysis of study data and the writing of scientific papers for publication
Develops data collection forms, procedural manuals, and other documents required for project implementation and evaluation
Ensures that all aspects of the following are completed: a. Study is conducted in accordance to the study protocol and contract b. Legal aspects adhere to state and federal regulations and guidelines c. Requirements of the Medical School and the University comply with the conduct of the study d. Technical requirements of the funding agency are met, including auditing requirements
Conducts site visits to evaluate staff and study activities
Coordinates sponsor audits
Represents the project to all related community agencies and organizations, serving as the study's liaison, spokesperson, and representative
Conducts meetings and visits with potential study sponsors to promote WFUHS as a study site
Attends and participates in national and local meetings related to the planning, operation, and evaluation of the study
Assists industry representatives (pharmaceutical, device, etc.) in planning and implementing future studies due to extensive knowledge in the specific field of research
Responsible for developing and monitoring the study budget(s)
Compiles and prepares financial progress reports
Tracks payments by sponsors, assuring correct amount received for each participant and testing
Performs other related duties incidental to the work described herein
Requirements:
Master's degree in Psychology, Nursing, or Basic Science with two years' relevant administrative and medical experience in research projects or other health-related activities
or, an equivalent combination of education and experience
One-year experience in a supervisory capacity
Excellent oral and written communication skills
Demonstrates knowledge of scientific principles
Experience in both single- and multi-center studies
What we offer:
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses
Family benefits such as adoption assistance and paid parental leave
Defined contribution retirement plans with employer match and other financial wellness programs