Manager Clinical Trials - Cardiology

Washington University in St. LouisAnn Arbor, MI
2dOnsite

About The Position

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.

Requirements

  • Education: Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
  • Work Experience: Clinical Research (1 Year)
  • Skills: Not Applicable
  • Driver's License: A driver's license is not required for this position.

Nice To Haves

  • Education: No additional education unless stated elsewhere in the job posting.
  • Certifications/Professional Licenses: Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA), Clinical Research Associate (CRA) - Association of Clinical Research Professionals (ACRP), Clinical Research Professional (CRP) - Association of Clinical Research Professionals (ACRP)
  • Work Experience: No additional work experience unless stated elsewhere in the job posting.
  • Skills: Clinical Project Management, Clinical Systems, Clinical Trials Administration, Deadline Management, Interpersonal Relationships, Leadership, Microsoft Excel, Microsoft Word, Oral Communications, Prioritization, SQL Databases, Stress Management, Written Communication

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.
  • Meets regularly with all staff, providing supervision and training.
  • With the Administrative Director and Medical Director, strategically plans and implements 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 Senior Clinical Research Associates and the Administrative Director.
  • Supports Senior Clinical Research Associate 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 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).
  • Performs other duties as assigned.

Benefits

  • Up to 22 days of vacation, 10 recognized holidays, and sick time.
  • Competitive health insurance packages with priority appointments and lower copays/coinsurance.
  • Take advantage of our free Metro transit U-Pass for eligible employees.
  • WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
  • Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
  • 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.
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