EPM Scientific’s Post

*Monitoring Clinical Drug Studies: Intermediate December 11-12, 2023, 12:00 p.m. - 7:00 p.m. Eastern             👉This course is an interesting mix of important topics for the more experienced #CRA looking to hone skills in site management, monitoring evaluation visits, and time management. It includes measures for developing tools for effective monitoring and more information about the audit/inspection process. The discussion topics and exercises reflect industry standards, real-world, practical situations to bolster critical thinking and align with regulations/guidelines. 💡Attendees who will benefit include CRAs and medical research associates with more than two years of experience, as well as clinical researchers involved in CRA management and/or study/project management. 👉Be sure to register here!   https://bit.ly/3sCdKrA #clinicalresearchassociate #sitemanagement #clinicalresearch #GCP #clinicaltrials #CRAevaluation

How can researchers ensure that clinical trial data is accurate and reliable?  Monitoring and Source Data Verification (SDV) are indispensable tools that ensure the accuracy, reliability, and ethical integrity of clinical research. Through actively safeguarding data quality, clinical operations teams are able to enhance research credibility, ultimately leading to advancements in medical knowledge and patient care!  "From meticulous oversight to real-world impact, Monitoring and SDV transform raw data into actionable insights, ensuring the integrity and reliability of clinical research."  MARC-CRO’s Clinical Operations Team  What We Offer in Clinical Operations:  Study feasibility and site qualification.  Management and facilitation of regulatory submissions.  Internal and external stakeholder management.  Project management according to study timelines.  Training, startup, and clinical trial initiation.  Managing the logistics of clinical trials.  Monitoring of clinical study sites.  Site management.  Facilitating communication between research teams and site staff.  Trial closeout and reporting.  To learn More about our CRO services, please visit our website: MARC (marc-eg.org)  or e-mail us at: [email protected]  #ClincalResearch #ClinicalOperations #Monitoring #SDV #CRO 

💥 Happy Tuesday, LinkedIn! 💥 As we approach the halfway point of 2024, to say these have been the busiest 6 months of my career would be an understatement! One major industry-wide trend I've noticed over the past 6 months has been the drastic increase in demand for Clinical Operations support. If you and your team could leverage external support within any of the key areas listed below, please feel free to contact me directly at [email protected] or through DM. 🔷 Clinical Trial Management: Planning, implementing, and overseeing clinical trials to gather data on the safety and effectiveness of medical devices. 🔷 Study Protocols: Developing protocols that outline the objectives, design, methodology, and statistical considerations of clinical trials. 🔷 Site Management: Identifying and selecting clinical trial sites, monitoring site activities, and ensuring compliance with Good Clinical Practice (GCP) guidelines. 🔷 Data Management: Collecting, managing, and analyzing clinical trial data to support regulatory submissions and decision-making. 🔷 Clinical Compliance: Ensuring that clinical trials are conducted in compliance with regulatory requirements and company policies. #MedicalDevices #RegulatoryAffairs #ClinicalTrials #StaffingSolutions #Innovation #Diagnostics #Trials #NPD #Operations #Consulting #Contracting #Support #Team

With hands-on experience in managing various aspects of clinical research projects, I have consistently demonstrated my skills in ensuring adherence to protocol guidelines, conducting regulatory submissions, and optimizing project management processes. My expertise in patient recruitment and personalized trial operations has been instrumental in driving successful clinical research initiatives. Let's connect to discuss how I can help your organization achieve its clinical research goals. #ClinicalOperations #ClinicalTrials #ClinicalResearch #PatientRecruitment #ProjectManagement

Maximize Your Potential as a CRC in 3 easy steps! As Clinical Research Coordinators (CRC), understanding the significance of long-term thinking is crucial for personal growth and advancing your career. Consistent effort and strategic planning can lead to remarkable achievements in the CRC role and beyond. 1️⃣ Increase your Knowledge: Every new protocol, regulatory update, or therapeutic insight you acquire adds to your expertise. 2️⃣ Build Relationships: Positive interactions with investigators, sponsors, and colleagues strengthen your professional network. 3️⃣ Invest in Professional Development: Treat your career as a journey. Consistently invest in your knowledge, skills, and relationships to achieve remarkable growth and make a lasting impact on patient care. 👉 For more, join 2650+ subscribers in my newsletter, click on the link in my bio! 🔔 Note: I will share the link to our monthly Q&A. Interest? Write me a YES below! Invest in your knowledge, nurture relationships, and watch your impact on patient care grow exponentially! Best, Jen  #ClinicalResearch #CareerGrowth #CRCs #clinicalresearchjobs #md #mbbs #img #medicine #career #development #researchanddevelopment #crc #clinicalresearchcoordinator #cra #ctm

💼🔬Joining the clinical research industry as a Clinical Research Associate (CRA) means overseeing and managing the execution of clinical trials. Acting as a liaison between study sponsors and research sites, CRAs ensure trials adhere to ethical, regulatory, and scientific standards, safeguarding data integrity and participant safety. Key skills include problem-solving, communication with hospital staff, and organization for efficient documentation management. With frequent travel to monitor hospitals and flexible remote work, CRAs play a vital role in advancing medical science and patient well-being through successful clinical trials. ✨ #ClinicalResearch #CRA #ClinicalTrials #TheraResearch

As a Clinical Operations Manager, I am privileged to play a key role in driving clinical trials forward, providing new indications and delivering robust scientific evidence to advance medical research. The Importance of Clinical Operations Management: Clinical operations management is at the heart of successful clinical trials. It encompasses planning, organizing, directing, and controlling the resources and processes necessary to conduct a study. The Pillars of Our Mission: Planning and Coordination: Developing detailed study plans and coordinating the efforts of multidisciplinary teams to ensure each phase is executed efficiently and on time. Site Management: Ensuring rigorous selection of clinical sites, training and supporting on-site teams, and monitoring compliance with protocols and regulations. Quality Oversight: Implementing quality control systems to guarantee data integrity and patient safety, while adhering to Good Clinical Practice (GCP) standards. Risk Management: Identifying potential risks, developing mitigation plans, and responding swiftly to challenges to minimize disruptions and deviations. Communication and Collaboration: Maintaining open and effective communication with stakeholders, including researchers, sponsors, regulators, and internal teams, to ensure synergy and transparency throughout the project. In Conclusion: Being a Clinical Operations Manager means being at the intersection of science, strategy, and management. Each day brings its challenges and opportunities, and it is with passion and determination that we work to advance clinical research. #ClinicalOperations #ClinicalTrials #Pharma #Innovation #Healthcare

15 questions for a Clinical Research Coordinator (CRC) role: 1. Can you explain your understanding of the role of a Clinical Research Coordinator? 2. What motivated you to pursue a career as a Clinical Research Coordinator? 3. How do you stay informed about the current regulations and guidelines in clinical research? 4. Can you describe your experience in coordinating and managing clinical trials? 5. What steps would you take to ensure participant safety and ethical conduct in a clinical trial? 6. How do you approach the process of participant recruitment for a clinical trial? 7. Can you explain the importance of informed consent in clinical research, and how would you ensure it is obtained properly? 8. How do you manage and organize study-related documentation and regulatory paperwork? 9. Describe a challenging situation you faced in a previous clinical research role and how you resolved it. 10. How do you handle adverse events and report them in a clinical trial setting? 11. What strategies do you use to ensure timely and accurate data collection from study participants? 12. Can you discuss your experience with electronic data capture (EDC) systems and data management? 13. How do you maintain communication and collaboration with investigators, sponsors, and study site staff? 14. What steps do you take to ensure compliance with Good Clinical Practice (GCP) standards? 15. How do you handle protocol deviations or non-compliance issues at a study site?

🚀 Thinking about the next step in your career as a Clinical Research Coordinator (CRC)? Here are some exciting paths you might explore: 🔍 Clinical Research Associate (CRA) - Monitor trials and ensure compliance. 📈 Clinical Project Manager (CPM) - Oversee trials from start to finish. 📊 Data Manager/Biostatistician - Analyze and interpret clinical data. 📜 Regulatory Affairs Specialist - Navigate regulatory requirements and submissions. 👩🔬 Clinical Research Director - Lead research departments and initiatives. 💼 Consultant - Offer expert advice on clinical research processes. Your CRC experience opens doors to a variety of dynamic roles in clinical research and beyond. Ready to take the leap? 🌟 #ClinicalResearch #CareerGrowth #ProfessionalDevelopment #ResearchCareers