Clinical Research Coordinator II (West County) - Allergy & Immunology Washington University in St. Louis

Scheduled Hours 40

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.

Job Description

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 participantsa 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.
  A

Physical Effort

• Typically sitting at desk or table.
  A

Equipment

• Office equipment.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education:

Bacheloras degree or combination of education and/or experience may substitute for minimum education.

Certifications:

The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.

Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience:

Clinical Research (2 Years)

Skills:

Not Applicable

Driver's License:

A driver's license is not required for this position.

More About This Job

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.

Preferred Qualifications

Education:

No additional education beyond what is stated in the Required Qualifications section.

Certifications:

Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA)

Work Experience:

No additional work experience beyond what is stated in the Required Qualifications section.

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)

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 A ... A or 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.

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.

• 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? Weave 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:

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 Universityas 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 a fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.