Manager Clinical Trials - Neurology

Position Summary
Directly responsible for the supervision, oversight, training and education of research coordinators, and quality assurance monitoring of data in the DRIVES and ARCHES studies. 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 industry-sponsored studies. Components of the role include protocol development, regulatory submission, grant writing, finances, human resources, and leadership of clinical research staff.

Job Description

Primary Duties and Responsibilities

Leadership of the Functional Research Groups

• Makes hiring and staffing decisions in the Laboratory with input and guidance from the PI.
• Orients and trains all staff in the DRIVES and ARCHES studies and assists in orienting new staff in the Regulatory and Protocol Development groups.
• Meets regularly with all staff, providing supervision and training.
• With the PI, plans strategically and implements plans for the lab, including staffing (setting current and future appropriate staff levels), education, adherence to federal regulations, and standard operating procedures for ensuring quality data collection.
• Provides feedback and performs annual performance evaluations for clinical research coordinators and students with assistance from Senior Clinical Research Associates and the Administrative Director.
• Supports PI 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 budgets for new studies.
• Assists with evaluating and entering study data into the database.
• Meets regularly with PI (at least weekly, but probably more often). Represents PI and laboratory at senior level meetings.
• Meets regularly with the PI and neurologists to assess the progress and goals of the research program.
• Leads regular meetings with the study team and members of each clinical area to plan for the successful implementation of upcoming studies.

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.
• Monitors collected data for accuracy of objective criteria.
• Facilitates accrual to high priority research studies.
• Oversees the quality assurance process for monitoring the collection of data for research, with assistance from the Quality Assurance and Safety Monitoring Committee (QASMC).

Other Functions

• Performs other duties as assigned.

Preferred Qualifications

• SOCRA or ACRP certification.
• 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. Must be intermediate level user of Excel and Word. Will be required to develop competency in several specialty computer systems, SQL, Study Manager and other clinical software systems.

Required Qualifications

• Bachelor’s degree in related field or equivalent level of training and experience.
• Minimum of one to two years’ experience in clinical research.

Grade
G14

Salary Range
$73,700.00 - $125,900.00 / 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.

Questions

For frequently asked questions about the application process, please refer to our External Applicant FAQ .

Accommodation

If you are unable to use our online application system and would like an accommodation, please email [email protected]  or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

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

Personal

• Up to 22 days of vacation, 10 recognized holidays, and sick time.

• Competitive health insurance packages with priority appointments and lower copays/coinsurance.

• Want to Live Near Your Work and/or improve your commute? Take advantage of our free Metro transit U-Pass for eligible employees. We also offer a forgivable home loan of up to $12,500 for closing costs and a down payment for homes in eligible neighborhoods.

• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.

Wellness

• Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!

Family

• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We’ve got you covered.

• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.

For policies, detailed benefits, and eligibility, please visit: https://hr.wustl.edu/benefits/

EEO/AA Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University’s policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.

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.