Primary Duties & Responsibilities:
Works under the Principal Investigator’s (PI) guidance to meet the research objective of the project.
Facilitates and implements study start-up activities including (but not limited to): trial feasibility assessment; study logistics; IRB (both local and central) submissions and other applicable regulatory requirements; budgetary and contract review and approval.
Provides direct patient care, including assessment, planning, implementation and evaluation of patients; documents, collects data and assists physicians.
Works with research team to identify, screen and enroll study subjects.
Ensures protocol requirements are met including (but not limited to): direct contact with research participants; collection of basic health information; coordination of study related procedures; handling, processing and shipping of research specimens, source documentation and data entry.
May train and supervise staff assigned to work on the research project(s).
Coordinates handling of specimens, administration of clinical trials, collection of source information and case reporting.
Prepares/submits reportable event reports to sponsor(s), IRBs and regulatory agencies in accordance with the study protocol and established policies, procedures, and regulations.
Collaborates with sponsor’s research associates during monitoring activities by providing study documentation, data clarifications and reports as necessary.
Authorizes payments to ancillary organizations for services rendered and reconciles payments from organizations serviced.
Demonstrates experience in clinical trials management including strong organizational skills, independence and resourcefulness and an increased responsibility for the day-to-day conduction and oversight of multiple clinical trials.
Provides oversight of administration of study medications and/or study interventions, as appropriate. Administers investigational products in approved settings.
Educates staff nurses caring for research patients by providing necessary information about the research study including intervention and potential adverse events and required study procedures.
Performs other duties incidental to the work described above.
Working Conditions:
Job Location/Working Conditions
Normal office environment
Exposure to blood-borne pathogens
Requires protective devices
Patient care setting
Direct patient care setting
Physical Effort
Typically sitting at desk or table
Typically bending, crouching, stooping
Occasional lifting (25 lbs or less)
Equipment
Office equipment
Clinical/diagnostic equipment
Education:
A diploma, certification or degree is not required.
Certifications/Professional Licenses:
Work Experience:
Skills:
Driver's License:
Education:
B.S. - Bachelor of Science - Nursing, B.S.N. - Bachelor of Science in Nursing
Certifications/Professional Licenses:
Work Experience:
Skills:
Active Listening, Clinical Research Coordination, Clinical Research Management, Clinical Research Methods, Clinical Research Operations, Clinical Techniques, Database Management, Detail-Oriented, Effective Written Communication, Electronic Health Records (EHR), Nursing Fundamentals, Oral Communications, Patient Recruitment, Reporting Tools, Spreadsheet Software, Statistical Analysis Software (SAS), Team CollaborationFor frequently asked questions about the application process, please refer to our External Applicant FAQ.
If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.
All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Personal
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
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/