Qureos Mentor

Kelly Science, Engineering, Technology & Telecom

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 Kelly Science &amp; Clinical is seeking a proactive Quality Assurance Coordinator for a specialty chemical company in Baytown, TX. This role is critical in ensuring compliance with quality regulations (federal, state, and local), improving processes, and implementing effective quality management systems. The ideal candidate will have experience in implementing quality programs, conducting and documenting risk assessments, and possess the initiative to follow through on projects until the desired results are achieved.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 
 
 
 
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 Develop, implement, and maintain quality management systems
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 Ensure compliance with relevant industry standards and regulations
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 Conduct regular audits and inspections of raw materials, in-process products, and finished goods
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 Monitor and analyze quality performance data, identifying areas for improvement
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 Identify safety hazards, support incident investigation, and ensure proper reporting to find root cause analysis and corrective actions
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 Collaborate with cross-functional teams to drive continuous improvement initiatives
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 Provide training and support on quality procedures and best practices
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 Qualifications:
 
 
 
 
 
 
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 Bachelor&rsquo;s degree in Chemistry, Chemical Engineering, Quality Management, or related field is preferred
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 Proven experience in quality assurance/control within a chemical manufacturing environment
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 Knowledge of quality standards and regulations relevant to the chemical industry
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 ISO 9001 knowledge / certification
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 Strong analytical and problem-solving skills
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 Excellent communication and teamwork abilities
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 Proficiency in quality management software and MS Office Suite
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 This is a Direct Hire position with a Monday-Friday day shift work schedule. If you meet the above qualifications, please submit your resume for immediate consideration.
 
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Quality Assurance Coordinator

<div>
 
 
 In-House Clinical Research Associate I
 
 
 
 
 
 
 
 SUMMARY:
 
 
 
 The In-House CRA I is based in the client&rsquo;s facility and will provide clinical research support and assistance in overseeing the conduct of clinical trials.
 
 
 
 
 
 
 RESPONSIBILITIES:
 
 
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 Work to ensure that trials are adhere to study protocols, applicable SOPs, FDA regulations, International Conference for Harmonization (ICH) / Good Clinical Practices (GCP) guidelines, and government regulations.
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 Evaluate, monitor, and document study results.
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 Exercise good clinical judgment and demonstrate professional conduct when interacting with investigational site personnel and sponsor representatives.
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 Monitor Clinical Research Organizations (CROs) and study management of multiple sites.
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 Additional duties include: document retrieval, archival, informed consent release forms, amendments, etc.
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 Responsible for the management of designated clinical trials including investigator recruitment and selection, analysis of potential patient recruitment, preparation of trial related documentation (protocols, case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing Ethics committee submissions with follow through to ensure successful outcome, investigator and study staff training.
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 Ensure procedures are in place for appropriate optimization of patients into the clinical trial.
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 Planning the requirements for clinical trial material (CTM), ordering CTM, setting up and monitoring the systems whereby the CRA can ship CTM to the investigator, maintaining procedures to account for the CTM, checking the expiration of CTM, and requesting extensions if necessary.
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 Approximately 15% local on-site co-monitoring
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 </ul>
 
 
 
 
 
 QUALIFICATIONS:
 
 
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 Bachelor&rsquo;s degree required
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 1-3 years combined experience with at least one of the following:
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 Medical device research experience
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 In-house pharma CRA experience (strictly Regional CRA experience will be considered)
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 Clinical Research Coordinator (site-level Study Coordinator) experience is required in lieu of CRA experience
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 On-site monitoring experience is preferred but not required
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 Electronic Data Capture (EDC) experience required (non-discriminatory)
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 </ul>
 
 Excellent oral and written communication skills
 
</div>

In-House Clinical Research Associate

<div>
 
 Kelly Science and Clinical FSP is currently seeking a Clinical Study Assistant a long-term engagement in the US with one of our Global Medical Device clients in
 
 Jacksonville, Florida.
 
 
 This position is hybrid with an onsite schedule of Monday-Wednesday
 
 This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
 
 
 
 
 
 Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.
 
 
 
 
 
 
 Clinical Study Assistant
 
 
 
 
 The requirements listed below under the job title are representative of the knowledge, skills, and/or abilities required to perform the duties of this position.
 
 
 
 
 
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 QUALIFICATIONS:
 
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 Minimum education required for competent performance:
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 BA/BS or equivalent years of experience required.
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 Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
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 0-2 years of clinical research experience
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 Knowledge of ophthalmology highly desirable, but not required.
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 Ability to problem-solve.
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 Good communication via written, verbal and listening skills.
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 Ability to report to corporate offices for routine, daily work.
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 Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities.
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 Ability to problem-solve.
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 Proficiency with MSWord, Excel and PowerPoint.
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 Equipment usage and abilities needed:
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 Medical Device industry experience is preferred.
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 Knowledge of ophthalmology is preferred.
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 Strong knowledge and understanding of application of GCP, specifically as it applies to investigative site conduct of clinical trials, is required.
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 Ability to successfully manage multiple competing priorities and adapt quickly to changing priorities is preferred.
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 Ability to problem-solve is required.
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 Effective communication via written, verbal and listening skills, with ability to effectively deliver training or informational presentations at internal or external meetings is preferred.
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 Proficiency with MS Word, Excel and PowerPoint is required.
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 Proven ability to operate in a home office environment with flexibility to travel and report to corporate offices, as appropriate is required.
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 </ul>
 
 
 
 
 
 JOB GOAL:
 
 
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 Provides administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations and SOPs. Close collaboration with other members within Clinical R&amp;D. Effectively manages multiple clinical study start activities to assure accurate and timely initiation for assigned clinical trials.
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 </ul>
 
 
 RESPONSIBILITIES:
 
 
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 Serving as internal support for all members of assigned teams.
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 Supporting investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation.
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 Supporting establishment and maintenance of the electronic Trial Master Files(eTMF) for assigned clinical trials.
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 Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate.
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 Supporting overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, as requested by the Study Manager, Lead CRAs, CRA sand other clinical trial team members.
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 Assist the study team with study startup procedures, including preparing site binders.
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 Assisting assigned clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned clinical trials.
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 Ensuring all equipment/supplies provided to investigative sites is appropriately tracked and reported to Study Manager and/or Lead CRA during study startup
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 Assist with contracts and purchase orders. Ensuring investigational product and, as applicable clinical supplies accountability, handling and documentation are sufficient to continue, accurate, updated and appropriately delegated.
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 Preparing, submitting and filing of quality monitoring visit reports and associated follow-up letters in a timely manner.
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 Providing regular updates to the Investigator of assigned investigative sites, Study Manager and/or Lead CRA with respect to study conduct and compliance
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 Monitoring overall progress of clinical trials by regularly attending project and/or clinical trial team meetings, reviewing team communications and sharing pertinent information with assigned investigative sites, Study Managers, Lead CRAs, CRAs and other clinical trial team members.
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 Maintaining audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites.
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 Supporting study payment activities or accruals, as assigned.
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 Ensuring all equipment/supplies provided to investigative sites is appropriately reported to Study Manager and/or Lead CRA.
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 </ul>
 
 
</div>

Clinical Study Assistant

<div>
 
 Kelly Science and Clinical FSP is currently seeking a Clinical Research Associate for a long-term engagement in the US with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
 
 
 
 
 
 
 This role is hybrid in Irvine, CA onsite Monday, Wednesday and every other Friday
 
 
 
 
 Travel will be 60% at its peak.
 
 
 
 
 
 
 Fraudulent Applications: All information provided during the application process will be verified. Misrepresentation of credentials, identity fraud, or use of proxy interviewers will result in immediate disqualification and may be reported to appropriate authorities.
 
 
 
 
 
 
 Description
 
 
 
 Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.
 
 
 
 
 
 
 
 Key Job Activities:
 
 
 Clinical Study Site Management Tasks
 
 
 
 
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 Verify safety and well being of study subjects are maintained for assigned study sites.
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 Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
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 Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
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 Accountable for study site performance, and providing high quality data according to overall project timeline.
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 Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
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 Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
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 Responsible for supporting patient recruitment and retention activities.
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 Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
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 Assists with internal communication of important clinical data and events.
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 Support organization of Investigator and other study training meetings, if required.
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 Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
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 Understand business value of clinical projects and balances overall business objectives and functional needs.
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 May be involved in other tasks to support Clinical Operations and Operating Company as needed.
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 Support the implementation of new clinical systems/processes.
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 Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
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 </ul>
 
 
 
 
 Administrative Tasks
 
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 Incumbent knows, understands, incorporates, and complies with all applicable laws and regulations relating to business activities, and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
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 May be asked to provide additional support to Clinical Operations staff, as needed.
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 </ul>
 
 
 
 
 
 Education
 
 
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 A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
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 </ul>
 
 
 
 
 
 Experience
 
 
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 Typically requires Bachelors degree with at least 2 years of relevant experience; Masters or PhD/MD/PharmD with at least 1 year of relevant experience.
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 Previous clinical research experience required.
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 Previous medical device monitoring or equivalent experience required.
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 Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
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 Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
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 </ul>
 
 
</div>

Clinical Research Associate

Join Kelly Science, Engineering, Technology & Telecom and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Kelly Science, Engineering, Technology & Telecom

About Company

Quality Assurance Coordinator

In-House Clinical Research Associate

Clinical Study Assistant

Clinical Research Associate