Clinical Research Coordinator III - Pediatrics Hematology & Oncology

Washington University in St. Louis; St. Louis (MO); On-site; USD 58,000 - 90,000; Full time

Benefits offered by this job

Vacation & Holidays

Health insurance

Metro U-Pass

Tuition assistance

Job summary

Washington University in St. Louis is seeking a Clinical Research Coordinator to oversee and coordinate complex clinical studies, ensure regulatory compliance, and support budget and billing processes.

The role may supervise staff and serves as a resource to research teams across departments. You will interact with PI and monitors, prepare essential documents, and ensure IRB and federal guidelines are followed, while promoting data quality and study integrity in a busy university hospital

Qualifications

• Bachelor’s degree or combination of education and/or experience may substitute for minimum education.
• Master's degree preferred for advanced roles.

Responsibilities

• Manages protocol study start up and study launch, submission, and maintenance of essential regulatory documents; assists in budget review and invoice tracking; assists in scheduling and facilitating site visits by external and internal monitors and auditors; provides high level of direct and indirect support.
• Works with PI to evaluate research procedures and develop plans for research projects; provides input on feasibility, cost, and workload for new clinical trials.
• Serves as a resource to clinical research staff, ensuring appropriate procedures and explaining policies; ensures projects comply with IRB and federal guidelines; develops and implements policies.
• Acts as a subject matter expert for clinical group; facilitates communication with PIs to meet study objectives; maintains cooperative relationships with divisions and departments; researches new methods to improve quality.
• Provides study coordination functions and data management for study projects; consents participants for non-therapeutic trials.
• Performs other duties incidental to the work described above.

Skills

Analyze Information

Clinical Research Management

Clinical Study Protocols

Database Management

Interpersonal Communication

Leadership

Oral Communications

Prioritization

Problem Solving

Research Projects

Spreadsheet Analysis

SAS (Statistical Analysis Software)

Supervision

Written Communication

Education

Bachelor's degree

Master's degree (preferred)

Job description

Position Summary

Position oversees and coordinates complex or multi-site clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation, preparation of regulatory compliance and interaction with other departments; responsible for assisting in budgetary reports and ensuring billing and regulatory compliance standards are maintained; may supervise clinical research staff

Location

SAINT LOUIS, MO 63110

Scheduled Hours

40

Job Description

Primary Duties & Responsibilities

• Manages protocol study start up and study launch, submission, and maintenance of essential regulatory documents; assists in budget review and invoice tracking; assists in scheduling and facilitating site visits by external and internal monitors and auditors; provides high level of direct and indirect support.
• Works with PI to evaluate research procedures; confers with PI to assist in developing plans for research projects; provides input of feasibility, cost, and workload in regards to participating in new clinical trials.
• Serves as a resource to clinical research staff, ensuring appropriate procedures, and explains policies and procedures; ensures that research projects are completed according to IRB and federal guidelines; Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; may participate in the hiring, training, and evaluation of clinical research staff.
• Serves as a subject matter expert for clinical group and acts as a resource for protocol related questions; facilitates communication with PIs to ensure that study objectives are met in a timely manner; maintains a cooperative relationship with Hematology/Oncology and other divisions and departments; researches and recommends new methods and procedures to maintain standards and improve quality.
• Provides study coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols; consents participants for non-therapeutic clinical trials
• Performs other duties incidental to the work described above.

Working Conditions

Job Location/Working Conditions

• Normal office environment

Physical Effort

• Typically sitting at a desk or a table

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.

Education

Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications & Professional Licenses

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

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

Work Experience

Clinical Research (3 Years)

Skills

Not Applicable

Driver's License

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

More About This Job

• BLS 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 requirements).
• Optional Based on Department) SOCRA/ACRP certification.

Preferred Qualifications

Master's degree

Certifications & Professional Licenses

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

Work Experience

Lead Position (1 Year)

Skills

• Analyze Information, Clinical Research Management, Clinical Study Protocols, Database Management, Interpersonal Communication, Leadership, Oral Communications, Prioritization, Problem Solving, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS), Supervision, Written Communication

Grade

C11

Salary Range

$58,300.00 - $90,400.00 / 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 [e-mail] 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.

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? 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 Statement

Washington University in St. Louis is committed to the principles and practices of equal employment opportunity. 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, citizenship (where prohibited by federal law), age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.