Clinical Research Specialist

Scheduled Hours

40

Position Summary

Provides leadership and oversees clinical research studies coordinated by the Pediatric Clinical Research Unit (PCRU). Serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation of clinical research; responsible for preparation of budgetary reports and ensures billing and regulatory compliance standards are maintained; may supervise clinical research staff.

Job Description

Primary Duties & Responsibilities:

• Provide leadership to PCRU staff acting as the Research Coordinator for Investigator Initiated and Industry Sponsored Clinical Research studies carried out by Principal Investigators.
• Works with PI to perform research protocol. 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.
• Assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
• Serves as a resource to the 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.
• 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.
• Researches and recommends new methods and procedures to maintain standards and improve quality.
• Performs other duties as assigned.

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:

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 Or Research (4 Years), Supervisory (1 Year)

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 requirements).

Preferred Qualifications

Education:

No additional education unless stated elsewhere in the job posting.

Certifications/Professional Licenses:

No additional certification/professional licenses unless stated elsewhere in the job posting.

Work Experience:

No additional work experience unless stated elsewhere in the job posting.

Skills:

Analytical Thinking, Clinical Research, Interpersonal Communication, Leadership, Oral Communications, Prioritization, Problem Solving, Written Communication

Grade

C13

Salary Range

$68, $105,500.00 / AnnuallyThe 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 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? 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:

EEO 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 University's 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.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

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