Under the direction of the principal investigator, the incumbent independently prioritizes assignments and completes ongoing tasks following established University, ORU and Federal research guidelines.
The incumbent is responsible for monitoring, verifying, and validating the integrity of various tools and data elements in one or more applications that support a core set of needs : including, but not limited to : regulatory tracking and reviews, study set-up, subject enrollment, budgeting, and invoicing.
The incumbent will receive assignments in the form of objectives with goals and the process by which to meet goals. Provides direction to staff according to established policies and management guidance.
Administers policies that directly affect subordinate staff. Recommends changes to department policies and practices. Identifies risks and responds accordingly.
Provide priority setting and work flow analysis.
MINIMUM QUALIFICATIONS
Nine years of related experience, education / training, OR a Bachelor’s degree in related area plus five years of related experience / training.
Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment.
Adaptable to quickly changing priorities.
Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research.
Critical thinking skills to evaluate issues and identify a potential solution.
Clear and concise communicator; good verbal and written communication skills; both.
Good interpersonal skills, including but not limited to : problem-solving, teamwork development, leadership, mentorship.
Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs.
Proven ability utilizing clinical trial management systems.
Experience working with Calpendo, REDCap, clinical conductor, and other clinical trial management software.
Demonstrated ability to lead clinical trials across several health outcomes and methods.
Experience with managing research for adherence to IRB, HIPAA and other federal research and security compliance guidelines.
Solid knowledge of clinical trial research.
Experience in project management in a biomedical or research organization.
Demonstrated knowledge of applicable technical project management policy analysis techniques and practices.
Technical working experience with Epic or other electronic health records (EHR) applications system for clinical research or operations and integrations.
Demonstrated knowledge of common organizational- or research-specific and other computer application programs.
PREFERRED QUALIFICATIONS
Experience with team and clinical trial management, and supervisory responsibilities.
Proven experience developing, deploying and managing web portals
SPECIAL CONDITIONS
Employment is subject to a criminal background check and pre-employment physical.
Pay Transparency Act
Annual Full Pay Range : $82,500 - $151,500 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent : $39.51 - $72.56
Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs.
The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position.
The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).