Scheduled Hours
40
Position Summary
Position assists research director and investigators as coordinator of a complex clinical research studies; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance. Works closely with WUSM IRB to ensure timely and accurate filing of required documentation and study materials.
Job Description
Primary Duties & Responsibilities
- Recruits, screens and enrolls subjects into a large variety of clinical trials ranging from observational studies to complex, interventional clinical trials. Must be adaptable to the higher acuity levels and diverse patient population in the BJH Emergency Department including flexibility in task prioritization to conduct time-sensitive enrollment and interventions.
- Ensures enrollment coordinators are compliant with protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors enrollment coordinators progress to include documentation and maintains tracker of non-compliance.
- May act as lead study coordinator on various clinical trials and assists supervisor with initial study/compliance/lab training and retraining of enrollment coordinators based on the study protocol. Provides annual compliance check for enrollment coordinators and maintains coordinators compliance folders which includes, licenses, CV and annual certifications.
- Confers with participants to explain purpose of study and obtain informed consent; explains diagnostic procedures and treatment plans to address participant/family concerns; administers questionnaires, orders labs, and completes assessments to ensure the subject visit is completed per protocol.
- Ensures compliance with protocol guidelines and requirements of regulatory agencies.
- Collects and reports adverse events to sponsor and/or IRB; notifies physicians of issues, and documents subject progress in the trial combining data collected from patients at the bedside, the clinical care team, and the electronic medical record.
- Serves as liaison with funding or sponsoring agency.
- Manages subject timelines for follow up appointments and assessments due.
- Ensures patients are compliant with study requirements. Distributes gift cards to study participants in alignment with study protocols. Follows department and school policies related to the handling and management of gift cards. Maintains proficiency for accurate screening and enrollment in many concurrently open studies including timely completion of required trainings and proactively addresses any knowledge gaps through additional discussion with the study team supervisor. Assists Regulatory coordinators with various duties including IRB submissions, study start and close out activities, and specimen shipping to the sponsor.
- Maintains the retention of all study records, including shipping to outside storage facility and organization of on-site storage room. Must comply with all university and hospital policies related to working in the clinical environment, including but not limited to, donning personal protective equipment, uniform requirements, and maintenance of basic life support certification.
- Performs other duties incidental to the work described herein.
Schedule
Must be available to work variable and off hour shifts including days, evenings, overnights and weekends.
Preferred Qualifications
- Bachelor’s degree and/or 3+ years of prior work experience in a clinical research environment.
- Prior work experience in emergency medicine.
- Registered nurse, paramedic, medical assistant or certified clinical research coordinator.
- Ability to work in higher acuity levels with diverse patient population.
- Interventional trial lead experience.
- Regulatory knowledge including navigating the myIRB system.
- Ability to independently manage a study from start up to close out.
Required Qualifications
- Bachelor’s degree plus a minimum of two years of clinical research experience; a combination of relevant work and education equaling six years may substitute for this requirement.
- Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements). BLS certification must be obtained within one month of hire date.
Grade
C10
Salary Range
$52,600.00 - $78,900.00 / 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.