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Job Details

Manager Clinical Trials - Cardiothoracic Surgery - 38803

Company name
Washington University

Salary
Open

Location
Saint Louis, MO

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EOE Statement:

Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status.

Job Type/Schedule:

This position is full-time and works approximately 40 hours per week. 

Department Name/Job Location:

This position is in the Department of Cardiothoracic Surgery.  This position is for the Medical School Campus.

Essential Functions:

POSITION SUMMARY:

Report directly to the Director of Clinical Trials within the Department of Surgery.

Oversees all clinical research and data management staff appointed within cardiothoracic surgery.

Improve the clinical research efforts by mobilizing and enhancing the strength and resources within the Division.

Form a consolidated education and training function as it relates to clinical research activities and staff for quality assurance and regulatory compliance.

Increase access to information for the Division and Departmental leadership regarding clinical research activity within cardiothoracic surgery.

Enhance faculty academic productivity through support for scientific publications and presentations.

PRIMARY DUTIES AND RESPONSIBILITIES

Clinical Research

Oversee the clinical research administration function of the cardiothoracic surgery trials within the Department.

Coordinates study procedures to provide available subjects, consistent with study procedures and techniques and verified documentation; supervises and trains personnel assigned to work on the study.

Recommend and implement procedural and process changes to improve the effectiveness, efficiency and compliance of the clinical research mission.

Work with leadership to increase clinical trial accruals.

Provide strong leadership in the development, implementation and improvement of clinical trial management systems and patient population screening tools/systems.

Provide continuous quality improvement by identifying, communicating and implementing best practices for clinical research administration.

Be an advocate for clinical researchers in working with the IRB and other University-based committee and processes engaged in clinical research. Help resolve issues between IRB and clinical investigators.

Promote translational and collaborative research. Advise division faculty on barriers and opportunities for improvement.

Evaluate feasibility of both industry and departmentally sponsored research proposals.

Prepare or assist regulatory personnel in preparation of required paperwork for new protocol submission to the Human Research Protection Office (HRPO) for clinical research protocols in cardiothoracic surgery.

Ensure staff compliance with federal regulations regarding the application of Good Clinical Practice in clinical research.

Work with principal investigator to develop departmental research studies and meet research objectives, according to established protocol.

Maintain files for review by the study sponsor, FDA, and HRPO.

Act as liaison between cardiothoracic surgery faculty, study sponsors, hospital staff, and regulatory authorities.

Employee Management

Develop internal educational and training programs/standards centered on improving good clinical research practices.

Conduct regular meetings for clinical research staff to discuss issues in clinical research (i.e. study accruals, data management, protocol development, subject enrollment/retention, etc).

New employee recruitment and orientation.

Performance evaluation and disciplinary action as required.

Resource for resolving staff conflicts.

Time sheets.

Recommendations for annual merit increases.

Research Finances

Oversee proper billing compliance with the University and Hospital for research and standard of care procedures for study patients.

Ensure accurate billing and receipt of reimbursement for industry sponsored studies according to each individual clinical trial agreement.

Develop processes with research staff for invoicing for payment and accounting for receipt of reimbursement.

Ensure accurate payment for study related procedures from research accounts.

In partnership with the Director of Clinical Trials for the Department of Surgery

Study budget preparation and negotiation of reimbursement for industry sponsored studies.

Facilitate in the execution of clinical trial agreements with the Division, University and industry sponsor.

Enhance operational performance, increase the quality of support to clinical investigator, and strengthen regulatory and institutional compliance.

Required Qualifications:

Bachelor’s degree in related field or equivalent level of training and experience.

Minimum of 1-2 years experience in clinical research. 

SOCRA or ACRP certification required within 12 months of hire and/or when eligible.

Preferred Qualifications:

Master’s degree preferred. 

Nursing or oncology background preferred.  

Working knowledge of techniques and methodologies used in developing, coordinating and managing clinical research projects.

Familiarity with federal guidelines governing clinical trials. 

Ability to provide leadership and guidance to junior staff. 

Ability to learn quickly and work independently and efficiently with minimal supervision.  

Ability to independently prioritize tasks and to work under deadline pressure.

Excellent verbal and written communication skills with the ability to interact effectively with a wide variety of individuals, including laboratory and clinical investigators, and support staff. 

Strong computer skills. Must be intermediate level user of Excel and Word.  Will be required to develop competency in several specialty computer systems, Siteman Cancer Center Database, SQL, Study Manager and other clinical software systems.

Salary Range:

The hiring range for this position is $68,577 - $89,190 annually.

Pre-Employment Screening:

Offers made for this position are contingent upon the successful completion of all required pre-employment screens, including a criminal background check, hair sample drug screen, and verification of required professional licenses, registrations, or certifications.

Benefits:

-Retirement Savings Plan

-22 vacation days

-8 Paid Holidays

-Sick Time

-Tuition benefits for employee, spouse and dependent children

-Free Metro Link/ Bus pass

-Free Life Insurance

-Health, Dental, Vision

-Health Savings Accounts (HSA)

-Long Term Disability Insurance

-Flex Spending Plan

-Other Benefits

Med School HR website (medschoolhr.wustl.edu)

Internal Applicant Instruction:

This position is grade G14.

Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account.  If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor.   To attach these documents, go to:  My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.

Company info

Washington University
Website : http://www.wustl.edu/

Company Profile
Washington University in St. Louis’ mission is to discover and disseminate knowledge, and protect the freedom of inquiry through research, teaching and learning. Washington University creates an environment to encourage and support an ethos of wide-ranging exploration. Washington University’s faculty and staff strive to enhance the lives and livelihoods of students, the people of the greater St. Louis community, the country and the world.

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