Manager Clinical Trials - Neurology

Scheduled Hours

40

Position Summary

Directly responsible for the supervision, oversight, training and education of research coordinators, and quality assurance monitoring of data serving as the Global Project Manager for the multisite Aging Adult Brain Connectome (AABC) study, the longitudinal extension of the impactful and successful Lifespan Human Connectome Project in Aging. This position requires the ability to clinically assess protocols for budgetary and logistical issues associated with the coordination and implementation of clinical trials for institutional studies, cooperative group studies, and pharmaceutical industry-sponsored studies. This individual will serve as a resource to provide comprehensive information to clinical research staff, promoting a smooth and seamless operation of clinical research; responsible for preparation of budgetary reports and ensuring that billing and regulatory compliance standards are maintained; supervises clinical research coordinators at each of the study sites, overseeing the individual sites and ensuring that all projects and cores meet goals and deadlines as set by the primary investigators (PI’s).

Job Description

Primary Duties and Responsibilities

Leadership of the All Study Sites

• Makes hiring and staffing decisions for the AABC study with input from the Administrative Core.
• Orients, trains and evaluates all clinical staff in the AABC, and assists in orienting new staff.
• Meets regularly with all staff, providing supervision and training by holding regular meetings with site coordinator and all staff as necessary.
• With the Administrative Core, plan strategically and implement plans for AABC, including funding/allocations to all sites, staffing (setting current and future a appropriate staff levels), education, adherence to federal regulations and writing and implementing all standard operating procedures for ensuring quality and consistent data collection.
• Ensures all sites have appropriate Data Use Agreements (DUA) and Material Transfer Agreements (MTA) in place. Responsible for acquiring and maintaining single IRB (sIRB) approval.
• Provides feedback and performs annual performance evaluations for Clinical Research Coordinators and Research Assistants with assistance from the PI.
• Supports site coordinators through initial performance improvement efforts and directs progressive performance management and disciplinary activities as required.
• Assesses new protocols for logistical and budgetary issues and creates a plan to address these.
• Creates and modifies budgets to meet new and ongoing project needs for all studies within the projects and cores.
• Assists with evaluating and entering studies into the database.
• Meets regularly with Administrative Core and other investigators. Serves as a conduit between investigators and clinical research staff; represents clinical staff at senior level meetings.
• Meets regularly with the MPI’s to assess the progress and goals of the research.
• Leads regular meetings with the study team and members of each clinical area to plan for the successful implementation of upcoming studies within AABC.

Oversight of Daily Activities

• Oversees the daily research activities for Senior Research Coordinators including compliance with protocol criteria and adherence to federal regulations.
• Oversees daily protocol management activities of Senior Research Coordinators.
• Functions equivalently to a Study Coordinator as needed, performing all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols.
• Creates a centralized database for the project and ensures timely transfer of data and samples, holding sites accountable to correct missing or incorrect data.
• Monitors collected data for accuracy of objective criteria.
• Facilitates accrual to high priority cohorts (e.g., underrepresented groups) within the research study.
• Creates checklists and case report/data collection forms, overseeing the quality assurance process for documenting and monitoring the collection of data for research, with assistance from the Administrative Core as necessary.

Other Functions

• Researches and recommends new methods and procedures to maintain standards and improve quality. Performs other duties incidental to the work described herein.
• Other duties as assigned.
  

Preferred Qualifications

• Master’s degree.
• Nursing or oncology background.
• Working knowledge of techniques and methodologies used in developing, coordinating and managing clinical research projects.
• Familiarity with federal guidelines governing clinical trials.
• Ability to provide leadership and guidance to junior staff.
• Ability to learn quickly and work independently and efficiently with minimal supervision.
• Ability to independently prioritize tasks and to work under deadline pressure.
• Excellent verbal and written communication skills with the ability to interact effectively with a wide variety of individuals, including laboratory and clinical investigators, and support staff.
• Strong computer skills. Intermediate level user of REDCap, Excel and Word. May be required to develop competency in several specialty computer systems, SQL, Study Manager and other clinical software systems.
• Willing to travel to all sites to train staff, ensure fidelity to data collection procedures and assist troubleshooting.

Required Qualifications

• Bachelor’s degree in related field or equivalent level of training and experience.
• Minimum of 1-2 years’ experience in clinical research.
• REQUIRED LICENSURE/CERTIFICATION/REGISTRATION: SOCRA or ACRP certification required within 12 months of hire and/or when eligible.

Grade

G14

Salary Range

$68,200.00 - $116,600.00 / Annually

The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.

Pre-Employment Screening

All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an 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.

Benefits Statement

Washington University in St. Louis is committed to providing a comprehensive and competitive benefits package to our employees. Benefits eligibility is subject to employment status, full-time equivalent (FTE) workload, and weekly standard hours. Please visit our website at https://hr.wustl.edu/benefits/ to view a summary of benefits.

EEO/AA Statement

Washington University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to an individual’s sex, race, color, religion, age, disability status, protected veteran status, national or ethnic origin, gender identity or expression, sexual orientation. Women, minorities, protected veterans and the disabled are strongly encouraged to apply.

Diversity Statement

Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

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