Manager Clinical Trials – Cardiology

Position Summary
Directly responsible for the supervision, oversight, training and education of research coordinators, and quality assurance monitoring of data in the Functional Research Groups. 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.

Job Description

Primary Duties & Responsibilities

Leadership of the Functional Research Groups

• Makes hiring and staffing decisions in the Functional Research Groups with input from the Administrative and Medical Directors of the Core.
• Orients and trains all staff in the Functional Research Groups, and assists in orienting new staff in the Regulatory and Protocol Development groups.
• Meet regularly with all staff, providing supervision and training.
• With the Administrative Director and Medical Director, plan strategically and implement plans for Functional Research Groups, including staffing (setting current and future a 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 Research Coordinators with assistance from Sr CRAs and the Administrative Director.
• Supports Sr CRA 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.
• Create budgets for new studies.
• Assists with evaluating and entering studies into the database.
• Meets regularly with Administrative Director (at least weekly, but probably more often). Represents Functional Research Groups at senior level meetings.
• Meets regularly with the oncologist 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

• Other duties as assigned.

Preferred Qualifications

• Master’s degree.
• 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 well 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 Excel and Word). Ability 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.
• One year of 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
$70,300.00 – $120,000.00 / 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.

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
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 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.

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