Clinical Research Coordinator II (West County) Allergy & Immunology
Saint Louis, MI - USA
Job Summary
Primary Duties & Responsibilities:
- Coordinates the development of forms questionnaires data bases and the application of research techniques; data collection and reviews journals abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies.
- Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants progress in the study; analyzes investigates and reports adverse events; makes decisions as when to notify physicians of issues when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
- Routinely recruits and enrolls study participants; participates in making determinations of eligibility based on diagnostic criteria and confers with participants to explain the purpose of the study and obtain completed informed consent; explains diagnostic procedures and treatment plans and addresses participant/family questions and concerns.
- Performs and/or coordinates the collection of protocol-defined study procedures and clinical assessments which frequently include Questionnaires Blood Draws ECGs Vital Signs Breathing Tests (PFTs) and Study Drug Administration when necessary.
- Processes and ships lab specimens to central labs in accordance with study-specific guidelines.
- Maintains study lab collection supplies.
- Receives logs and stores study drugs in accordance with study-specific guidelines.
- Maintains appropriate study-related regulatory documentation including regulatory files study participant data and source documentation.
- Maintain appropriate recordkeeping and organization of many types of information and data including database creation data management and data entry.
- Preparation and management of various regulatory documents.
- 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.
- May train and supervise staff assigned to work on the research project(s).
- Performs other duties as assigned.
Working Conditions:
Job Location/Working Conditions
Patient care setting.
Physical Effort
Typically sitting at desk or table.
Equipment
Office equipment.
Education:
Bachelors degree or combination of education and/or experience may substitute for minimum education.
Certifications/Professional Licenses:
Work Experience:
Skills:
Drivers License:
Required Qualifications:
- Basic Life Support certification must be obtained within one month of hire date.
- Basic Life Support certification (Online BLS certifications those without a skills assessment component are not sufficient to meet the BLS requirement).
Preferred Qualifications:
- Prior experience with EPIC and/or OnCore.
Education:
No additional education unless stated elsewhere in the job posting.
Certifications/Professional Licenses:
Work Experience:
Skills:
Adaptability Clinical Research Clinical Study Protocols Communication Database Management Detail-Oriented Epic EHR Highly Developed Interpersonal IRB Submission Learning New Concepts Learning Techniques Microsoft Office Multitasking Phlebotomy Prioritization Regulatory Documents Research Projects Spreadsheet Analysis Statistical Analysis Software (SAS)For 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 emailor call the dedicated accommodation inquiry number at 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 Weve 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: StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity. It is the Universitys policy to provide equal opportunity and access to persons in all job titles without regard to race ethnicity color national origin citizenship (where prohibited by federal law) age religion sex sexual orientation gender identity or expression disability protected veteran status or genetic information.
Required Experience:
IC