Qureos Mentor

Fortrea

<div>As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.
We are currently seeking a PRN Research Technician, to lead and support our Clinical Pharmacology Start-up team in initiating Early Phase clinical trials for our clients with maximum speed and efficiency.
This is a casual, office-based position in Dallas, TX. Multiple openings.
If you join us, you will work with some of the world&acute;s leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability, and pharmacokinetics of a new drug.
Many Technicians are drawn to their profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, you&acute;ll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know you&acute;ll touch many patient&acute;s lives around the world.
WHAT YOU WILL DO
You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.
Other key responsibilities:<ul><li>
Accurately perform blood pressure, venipuncture, weights, pulse, respiratory rate, and temperature readings</li><li>
Preparation and accurate recording of ECGs/Holters</li><li>
Collection and processing of biological samples as specified in the protocol and ensures the proper distribution of those samples.</li><li>
Monitors meals to ensure dietary compliance by research participants.</li><li>
Assist in the preparation of rooms and medical equipment.</li><li>
Assist with screening procedures as needed.</li><li>
Maintain a clean, safe, and efficient working and study environment.</li><li>
Undertake any other duties as required.</li></ul>
YOU NEED TO BRING&hellip;<ul><li>
High School Diploma or equivalent</li><li>
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li><li>
EMT, Phlebotomy, CMA or CNA certification, preferred.</li><li>
0 -1 year of clinical research experience</li></ul>
Previous clinical experience is ideal, but not a must. We are open to consider recent graduates or any recent clinical experience.
The important thing for us is you are comfortable working in an environment that is:<ul><li>
Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.</li><li>
Changing priorities constantly asking you to prioritize and adapt on the spot.</li><li>
Teamwork and people skills are essential for the study to run smoothly.</li><li>
Technology based. We collect our data directly into an electronic environment.</li></ul>
What do you get?
Regular, full-time, or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:<ul><li>
Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)</li><li>
401(K)</li><li>
Paid time off (PTO)</li><li>
Employee recognition awards</li><li>
Multiple ERG&rsquo;s (employee resource groups)</li></ul>
Learn more about our EEO &amp; Accommodations request here.</div>

PRN Research Technician I - Dallas, TX

<div>Job Overview:<ul><li>
Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. It is the responsibility of the post holder to provide all clients, both internal and external, with the appropriate quality of service in a safe and cost effective manner. The individual will be expected to comply with the legal requirements of the Health and Safety at Work Act 1974, the COSHH regulations 1989 and the EC (European Commission) Directives 1992/3 as documented in the Company&rsquo;s Health and Safety Manual.</li></ul>
Summary of Responsibilities:<ul><li>
Assume accountability of quality of the deliverables and implementation of quality processes with minimal support from the Manager.</li><li>
Function as a Point of Contact for the delivery team for regulatory updates, quality concepts, applicable procedures, practices, and conventions on the assigned projects.</li><li>
Act as the process and quality expert for the Client.</li><li>
Work with other team members to analyze Quality findings and help develop action plans.</li><li>
Ownership of responding to and addressing periodic client quality reviews and other ad-hoc client quality findings.</li><li>
Perform ongoing review of a sample of various cases or safety reports for global regulatory submissions, labeling / regulatory documents for Fortrea clients e.g., Annual Reports (IND and other), PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, centralized SPC&rsquo;s, Med Guides etc.</li><li>
Assist with the overall functional quality operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports).</li><li>
Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines.</li><li>
Provide adequate oversight to ongoing sample case reviews and perform reviews as required. Publish quality metrics based on this review and use it to ensure deliverables meet agreed quality targets.</li><li>
Identify, report quality trends to internal and external stakeholders, suggest corrective actions and monitor the execution and closure.</li><li>
Assume ownership of quality of reports and CAPAs as assigned. Ensure that CAPAs are implemented for the assigned project.</li><li>
Conduct process review in coordination with Project Manager and Quality Manager to identify process gaps and proactively coordinate with the delivery team to develop process standards and suggest process improvements.</li><li>
Measure and track audit readiness for assigned projects.</li><li>
Lead authoring, reviews, training and distribution of SOPs, project specific Work Instructions / convention documents etc.</li><li>
Work with individuals in identifying training needs based on quality review findings.</li><li>
Assist in designing sign-off criteria, development and tracking of training schedule and training material for new hires and existing team.</li><li>
Ensure that periodic feedback is provided to the team based on review findings.</li><li>
Initiate discussion forums on Quality errors within assigned project and identify process improvements, share best practices across projects.</li><li>
Communicate with internal Subject Matter experts to get clarification on case-processing queries and providing feedback to team.</li><li>
Responsible to coordinate and handle queries during the client or external audits of the assigned projects.</li><li>
Assume accountability of supporting the client during regulatory inspections and ensuring quality and timely completion of inspection requests.</li><li>
Responsible for developing Quality Management Plan and / or contributing to the Quality Agreement for assigned projects.</li><li>
Support Computer System Validation related activities as required.</li><li>
To respond/review to medical information queries/product quality complaints/general queries that may be received over the telephone call, email, fax etc.</li><li>
Review recorded information that may be received over the telephone call, email, fax etc.</li><li>
Execute drug safety data management processes - a combination of call intake review, call dialogue documentation review and case follow-up.</li><li>
Guide safety associates in managing voice calls (as required).</li><li>
Perform any other support activities as assigned &ndash; tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from multiple sources.</li><li>
Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Manager.</li><li>
Perform Analysis of data and if required, suggest strategies for process improvement/excellence.</li><li>
Perform and Review of analysis of data performed and drive strategies for process improvement/excellence.</li><li>
All other duties as needed or assigned.</li></ul>
Qualifications (Minimum Required):<ul><li>
Bachelors/Masters/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, or related area.</li><li>
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.</li></ul>
Experience (Minimum Required):<ul><li>
Five years of overall work experience in the pharmaceutical industry, biotechnology, or CRO industry primarily in Pharmacovigilance / Safety writing with at least Two years&rsquo; experience in Peer review/Quality review.</li><li>
Knowledge of regulatory requirements viz. GPV and applicable EU and FDA guidelines.</li><li>
In-depth understanding of case processing and assessment.</li><li>
Knowledge of Quality Assurance.</li><li>
Awareness of lean methodology concepts.</li><li>
Technical proficiency with Microsoft Office suite of applications.</li></ul>
Preferred Qualifications Include:<ul><li>
Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred.</li><li>
Experience in assessing quality of a case/safety report from a medical, scientific and documentation perspective is preferred.</li></ul>
Physical Demands/Work Environment:<ul><li>
Office Environment or remote.</li><li>
Available for travel 10% of the time including overnight stays as necessary consistent with project needs and office location.</li></ul>
Learn more about our EEO &amp; Accommodations request here.</div>

Associate Manager - Process Compliance Review and Analysis

Join Fortrea and explore 2   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.

Fortrea

ABOUT_COMPANY

PRN Research Technician I - Dallas, TX

Associate Manager - Process Compliance Review and Analysis