Clinical Research Coordinator II (West County) - Allergy & Immunology

Position Summary

Assists investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; manages and records all phases of study protocol as required by sponsoring agency to ensure compliance.

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.

Required Qualifications

• Bachelor's degree or combination of education and/or experience may substitute for minimum education.
• Clinical Research (2 Years) work experience.
• Basic Life Support certification must be obtained within one month of hire date. (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.
• Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP) or Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA).

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)

Pay

$54,600.00 - $81,900.00 / Annually

Benefits

• Personal: Up to 22 days of vacation, 10 recognized holidays, and sick time.
• Health: Competitive health insurance packages with priority appointments and lower copays/coinsurance.
• Transit: Free Metro transit U-Pass for eligible employees.
• Retirement: Eligible employees receive 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: 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Adult care resources available.
• Tuition: 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.