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24 days old

Clinical Trials Office Director

Kelly Services
Shreveport, LA 71133
Kelly Scientific is seeking a **Clinical Trials Office Director** for a role in **Shreveport, LA** who will oversee human subjects research, support personnel and provide key leadership to research operations within an academic environment.



**This is a DIRECT HIRE opportunity that offers relocation assistance.**



**Work hours:** Monday through Friday, 8:00AM to 5:00PM, additional hours may be required.




+ In particular, the position plays an important role in a renewed emphasis on clinical and human-subjects research. This position requires an individual who can assist the University in enhancing its research infrastructure, program depth, as aligned with the goals of the Human Subject and Clinical Research program. This position manages the Human Subject Research Support infrastructure and constantly evaluates the workload and performance of human subject research support personnel.

+ The Clinical Trials Office supports the regulatory staff, the clinical research coordinators (CRCs), and the campus. The office promotes the safety and protection of individuals involved in human subject research by providing support, guidance, oversight, to facilitate ethical and scientifically sound research for Principal Investigators who do not have the staff to serve in these roles. The office is responsible for overseeing the financial aspects of clinical trials from the budgeting process to start-up to the end of the trial.

+ This position assists in the evaluation of the controls for the processes used to manage Clinical Trials while implementing Clinical Trial Management processes and best practices. The controls and best practices must conform to the guidelines laid out by the findings of any internal or legislative audits.



**RESPONSIBILITIES INCLUDE:**




+ The review of Confidentiality Disclosure Agreement and Clinical Trial Agreement templates from sponsor/CRO for compliance with institutional and state guidelines and the protocol.

+ Providing clear feedback on institutional and state requirements to sponsor/CRO.

+ Working with the budget coordinator to develop a budget that covers all procedures required by the protocol and compiles and interprets Pl, sponsor/designee comments or other contract activities.

+ Corresponding with researchers and sponsor/CRO and responding to requests for information

+ Gathering information and background material needed to create contracts.

+ Submitting completed contracts to the sponsor/CRO for signature and ensuring that completed contracts are copied, scanned and filed to send to the appropriate parties and files.

+ Establish processes to ensure a seamless approach to human subject protection and research administration. The Position's areas of focus are the following: The Institutional Clinical Trial Management Program, and the Human Subject Research Support infrastructure for the institution.

+ Early identification of and action to correct identified problems in the conduction of IRB approved Human Subject Research as related to the areas of focus above.

+ Maintain responsibility for all business, process, performance, and problem-solving activities undertaken by the Clinical Trial Office components.

+ Develop and adhere to the annual operating budget for the Clinical Trials Office and its components. Oversee invoicing and collections of IRB review fees, Billing Compliance fees and procurement and payment of business expenses, travel and other program needs.

+ Provides oversight and leadership for the Human Subject Research group.

+ Provide oversight and management of personnel and daily operations of the office including the hiring and the performance management of staff.

+ Interprets and applies federal and state laws, regulations, institutional polices, and guidelines to protect human subjects and to ensure institutional compliance.

+ Provides consultation and guidance to faculty, Principal Investigators and other research staff regarding negotiation of the contracts with the appropriate research documents.

+ Provides guidance regarding institutional and state guidelines and requirements;

+ Provides ethical and technical review of protocols so that all institutional, state, and federal guidelines are met and that the PI and designee understand how those requirements are met and their responsibilities in continuing compliance with those guidelines.

+ Reviews study materials for language and content to identify all responsibilities of the institution. Determines that contracts are complete and meets all criteria prior to approval;

+ Queries investigators/research staff for additional information/clarification as requested by the sponsor/CRO.

+ Assists with notifying principal investigators of correspondence from the sponsor in regard to the contract.

+ Works with the budgets coordinator to ensure that all budgets and contracts are completed in a timely manner.



**Preferred Experience:**




+ Prior experience within a Director or Clinical Trial Manager capacity preferred, however relevant leadership experience within a CRO or Scientific/Clinical space will be considered

+ Masters in Business/Science with 1 yr clinical trials experience in academic/healthcare setting or a Bachelors in Business/Science with 3 years of clinical trials exp.



**Apply Today for Immediate Consideration!**




**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-11-11 Expires: 2020-12-12

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Clinical Trials Office Director

Kelly Services
Shreveport, LA 71133

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