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11 days old

Clinical Research Regulatory Specialist

Kelly Services
Dallas, TX 75219
**Clinical Research Regulatory Specialist**


Kelly Science and Clinical is currently recruiting for a temp-to-hire, full-time Clinical Research Regulatory Specialist in Dallas, TX.


**Summary:**


The Clinical Research Regulatory Specialist supports clinical research activities through the development of protocol-specific documents and reports for research activities from initial submission through study closure. The primary focus for this position is on development, submission, maintenance, filing and reporting of regulatory documents to achieve and maintain compliance with all internal, external, and federal policies and regulations pertinent to research involving human subjects. This position also provides regulatory guidance and direction to internal clinical research programs to ensure compliance with all applicable policies, procedures, and regulations.


**Responsibilities:**


+ Prepares, facilitates, and coordinates the process for accurate and timely submission of Institutional Research Board (IRB) applications for protocol revisions or amendments

+ Ensures completeness of all documents and that the submission packet meets the IRBs revision submission requirements

+ Follows-up, communicates, and facilitates responses to queries of the IRB, Sponsor, and other committees based on submission reviews.

+ Coordinates the preparation and submission of consent forms in compliance with the regulatory requirements of federal, state, and local agencies governing biomedical research

+ Obtains Sponsor approval of consent form prior to submission to the IRB

+ Collaborates with research nurses, clinical research coordinators, and investigators in the preparation of regulatory documents.

+ Ensures that regulatory binders are audited and maintained.

+ Monitor workload and status of pending protocols and associated supporting documents to provide efficient customer service to the research team.

+ Participates in Quality Assurance (QA) programs related to overall project and patient data, as needed.

+ Oversees QA initiatives for the department to support research staff and leaders during sponsor and FDA audits.

+ Facilitates investigator-initiated research by ensuring all regulatory requirements are met.


**Education/Qualifications/Skills:**


+ Associates Degree with 1-2 years of relevant experience; oncology background preferred

+ **Must be able to juggle multiple tasks at one time**

+ Very Detail-oriented and organized

+ Strong written and oral communication skills

+ Knowledgeable of regulations surrounding data management

+ Ability to effectively utilize common clinical trial software

+ Proven leadership skills in project management tools and techniques

+ Strong computer skills, including Microsoft Office, Excel, and PowerPoint

+ Ability to manage time with regards to sensitive projects to meet deadlines

+ Strong ability to establish and maintain effective working relationships


**Pay** : Negotiable and Depending on experience


**Hours** : 8AM 5PM, M-F


**For immediate consideration, please contact me directly at Tierra.Barbour@kellyscientific.com or 804-991-0745**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-01-10 Expires: 2022-02-10

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Clinical Research Regulatory Specialist

Kelly Services
Dallas, TX 75219

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