Grant Smillie’s Post

🌟 Star of the Week: 🌟 Working with a dedicated Clinical Research Professional, making significant contributions in our industry! With over 15 years of extensive experience, this star candidate has excelled in managing clinical trials that comply with Good Clinical Practice (GCP) and EU regulations across various therapeutic areas. Along with specializing as a Study Start-up specialist throughout their career. Here are a few highlights of their experiences to date: - Project Leadership: Currently serving as Regional Clinical Operation Lead at a Biopharma company, overseeing clinical trials from initiation to completion, ensuring timely delivery within budget. - Global Study Involvement: Proven track record in managing clinical trials across multiple countries, ensuring compliance and safety while achieving successful outcomes. - Regulatory Compliance: Maintains high standards of regulatory adherence, proactively addressing issues to uphold project integrity. - Vendor and CRO Management: Skilled in managing vendor relationships, overseeing communication to ensure effective data collection and trial conduct. - Diverse Therapeutic Expertise: Successfully managed trials in Neurosciences, Oncology, and CAR-T products, enhancing resource allocation and project success during tenure at a reputable Pharma company. Join us in celebrating this contractors experiences and expertise along with the outstanding contributions and dedication to advancing clinical research! Want to learn more about our star of the week, get in touch to organise a call with me and to go into further details of their strength and attributes. 📩 callum.quilter@epmscientific.com #ClinicalResearch #StarOfTheWeek #ProjectManagement #GlobalStudies #ClinicalTrials #studystartup #contractor #freelance #clinicaloperations

Launching Your Clinical Research Career: SMO vs. CRO? A recent LinkedIn connection asked a fantastic question 👇 Should they begin their clinical research career at a Site Management Organization (SMO) or a Contract Research Organization (CRO)? Both offer valuable entry points, so let's break down the pros and cons: 🔸SMO (Site Management Organization): Oversees clinical trial procedures at individual research sites, ensuring protocol adherence. They work under the direction of sponsors and CROs Pros for Beginners: →1.Hands-on Experience: SMOs provide a deep dive into site operations, ensuring meticulous protocol adherence. This is ideal for understanding the nuts and bolts of clinical trials. →2.Direct Patient Interaction: SMOs work closely with research sites and patients, fostering a strong understanding of the human element in research. →3.Specialization Potential: As they gain experience, they can specialize in specific therapeutic areas. 🔸CRO (Contract Research Organization): Manages various aspects of clinical trials for sponsors (pharmaceutical companies). CROs have a hierarchical structure with departments specializing in data management, regulatory affairs, project management, and site monitoring (which may include working with SMOs). Pros for Beginners: →1.Broader Exposure: CROs handle various clinical trial aspects, offering a wider range of experiences (data management, regulatory affairs, project management). →2.Diverse Project Opportunities: CROs work on numerous trials across different phases and therapeutic areas, fostering a well-rounded skill set. → 3.Career Growth & Development: CROs often have larger teams and established training programs, supporting career development. Choosing the Right Path: Passionate about in-depth site operations and patient interaction? An SMO might be ideal. Drawn to a broader view, diverse projects, and structured career development? A CRO could be a great fit. Ultimately, the best choice depends on your interest Happy Clinical research journey! 🔥🚀 Shrinath Deshmukh 🇮🇳 #clinicalresearch #careers #CRO #SMO #healthcare #clinicaltrials

💥 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 cdixon@alku.com 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

I once hired a CRA who outperformed PhDs. Their secret? A razor-sharp focus on practical skills. Top certifications that actually move the needle: • Regulatory Affairs Certification (RAC) • Data Management in Clinical Trials • Project Management in Clinical Research • Clinical Trial Monitoring These aren't just fancy titles. They're toolkits for solving real challenges in clinical research. Remember: Knowledge without application is just trivia. How are you applying your skills today? #ClinicalTrials #ProfessionalDevelopment #ResumeTips #ClinicalResearch #JobSearch #India

How do you know which is the best career path for someone who wants to become a Clinical Trial Manager? What can you do to make it the smoothest transition? There are many different career paths that lead to the CTM role. Knowledge and experience are key for anyone who is interested in clinical trial management. In the FREE guide, How to Transition to the CTM Role, we discuss the most common career paths to CTM and 8 steps to help you on your way to the role. FREE download here -->> https://lnkd.in/gyWAFt9k #clinicaltrials #ctm #clinicalresearch

🌟 Star Candidate of the Week 🌟 We are excited to introduce our standout candidate, a highly experienced Clinical Project Manager with over 10 years of experience in the clinical management and over 15 years in therapeutic experiences. Here are some of the key highlights: 🎄Experienced Clinical Project Manager with extensive experience managing global clinical trials across various phases (I-IV) and therapeutic areas, including oncology, cardiology, and infectious diseases. 🎄Proven track record in leading cross-functional teams and overseeing CROs and external vendors to ensure timely and budget-compliant delivery of clinical studies. 🎄Expert in patient recruitment strategies, successfully boosting enrollment rates through tailored site engagement and effective communication with local healthcare providers. 🎄Skilled in regulatory compliance, with extensive experience in preparing and reviewing study documents, ensuring adherence to ICH-GCP guidelines, and maintaining inspection readiness. 🎄Strong supervisory and conflict resolution abilities, demonstrated by effectively managing stakeholder relationships and resolving complex issues to maintain data integrity and study progression. 🎄Certified GCP Auditor, with additional training in auditing clinical development documents and inspection readiness, ensuring high-quality standards in clinical trials. If you're looking for a dedicated professional to lead your next clinical trial to success, this candidate is ready to make an impact! #ClinicalResearch #ClinicalTrials #ProjectManagement #GCP #PatientRecruitment #RegulatoryCompliance #ClinicalOperations #CPM #clinicalprojectmanager #trialmanagment

Over the last few weeks, I have received questions from study coordinators about how to prepare to become a CRA. 𝘏𝘦𝘳𝘦’𝘴 𝘺𝘰𝘶𝘳 10-𝘴𝘵𝘦𝘱 𝘤𝘩𝘦𝘤𝘬𝘭𝘪𝘴𝘵 𝘵𝘰 𝘮𝘢𝘬𝘦 𝘵𝘩𝘦 𝘵𝘳𝘢𝘯𝘴𝘪𝘵𝘪𝘰𝘯 𝘢𝘯𝘥 𝘢𝘤𝘤𝘦𝘭𝘦𝘳𝘢𝘵𝘦 𝘺𝘰𝘶𝘳 𝘤𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘳𝘦𝘴𝘦𝘢𝘳𝘤𝘩 𝘤𝘢𝘳𝘦𝘦𝘳! If you’re a Clinical Research Coordinator (CRC) aiming to make the leap to Clinical Research Associate (CRA), this is for you: ↳ 1. 𝐄𝐚𝐫𝐧 𝐲𝐨𝐮𝐫 𝐆𝐂𝐏 𝐜𝐞𝐫𝐭𝐢𝐟𝐢𝐜𝐚𝐭𝐢𝐨𝐧 It’s the foundation for everything in clinical research. ↳ 2. 𝐒𝐭𝐫𝐞𝐧𝐠𝐭𝐡𝐞𝐧 𝐜𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐬𝐤𝐢𝐥𝐥𝐬 As a CRA, you'll be the bridge between sites, sponsors, and CROs. ↳ 3. 𝐌𝐚𝐬𝐭𝐞𝐫 𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐭𝐫𝐢𝐚𝐥 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞 (𝐂𝐓𝐌𝐒, 𝐞𝐓𝐌𝐅) These tools will be your best friend as a CRA. ↳ 4. 𝐋𝐞𝐚𝐫𝐧 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐫𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬 𝐟𝐨𝐫 𝐦𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 Stay compliant, stay confident. ↳ 5. 𝐁𝐮𝐢𝐥𝐝 𝐚 𝐧𝐞𝐭𝐰𝐨𝐫𝐤 𝐨𝐟 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐩𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥𝐬 Your network is your net worth! ↳ 6. 𝐕𝐨𝐥𝐮𝐧𝐭𝐞𝐞𝐫 𝐟𝐨𝐫 𝐦𝐨𝐧𝐢𝐭𝐨𝐫𝐢𝐧𝐠 𝐭𝐚𝐬𝐤𝐬 𝐚𝐭 𝐲𝐨𝐮𝐫 𝐬𝐢𝐭𝐞 Hands-on experience is pure gold. ↳ 7. 𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝 𝐩𝐫𝐨𝐭𝐨𝐜𝐨𝐥 𝐝𝐞𝐯𝐢𝐚𝐭𝐢𝐨𝐧𝐬 & 𝐫𝐞𝐩𝐨𝐫𝐭𝐢𝐧𝐠 CRAs need to catch and report these like a pro. ↳ 8. 𝐆𝐚𝐢𝐧 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞 𝐰𝐢𝐭𝐡 𝐝𝐚𝐭𝐚 𝐜𝐨𝐥𝐥𝐞𝐜𝐭𝐢𝐨𝐧 & 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 Data is the backbone of clinical trials. ↳ 9. 𝐏𝐫𝐞𝐩𝐚𝐫𝐞 𝐟𝐨𝐫 𝐢𝐧𝐭𝐞𝐫𝐯𝐢𝐞𝐰𝐬 𝐰𝐢𝐭𝐡 𝐂𝐑𝐎𝐬 𝐚𝐧𝐝 𝐏𝐡𝐚𝐫𝐦𝐚 Know your stuff, show your passion. ↳ 10. 𝐒𝐭𝐚𝐲 𝐮𝐩𝐝𝐚𝐭𝐞𝐝 𝐰𝐢𝐭𝐡 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐭𝐫𝐞𝐧𝐝𝐬 & 𝐛𝐞𝐬𝐭 𝐩𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬 Keep learning and growing. ✨ 𝘠𝘰𝘶’𝘷𝘦 𝘨𝘰𝘵 𝘵𝘩𝘪𝘴! 𝘛𝘳𝘢𝘯𝘴𝘪𝘵𝘪𝘰𝘯𝘪𝘯𝘨 𝘧𝘳𝘰𝘮 𝘊𝘙𝘊 𝘵𝘰 𝘊𝘙𝘈 𝘪𝘴 𝘢 𝘨𝘢𝘮𝘦-𝘤𝘩𝘢𝘯𝘨𝘦𝘳 𝘧𝘰𝘳 𝘺𝘰𝘶𝘳 𝘤𝘢𝘳𝘦𝘦𝘳. 𝘍𝘰𝘤𝘶𝘴, 𝘭𝘦𝘢𝘳𝘯, 𝘢𝘯𝘥 𝘯𝘦𝘵𝘸𝘰𝘳𝘬 𝘺𝘰𝘶𝘳 𝘸𝘢𝘺 𝘵𝘰 𝘴𝘶𝘤𝘤𝘦𝘴𝘴! 𝘐𝘧 𝘺𝘰𝘶 𝘯𝘦𝘦𝘥 𝘢 𝘳𝘰𝘢𝘥𝘮𝘢𝘱, 𝘋𝘔 𝘮𝘦! 👣 𝐅𝐨𝐥𝐥𝐨𝐰 𝐦𝐞 𝐟𝐨𝐫 𝐦𝐨𝐫𝐞! 🔁 𝐑𝐞𝐩𝐨𝐬𝐭 𝐭𝐨 𝐡𝐞𝐥𝐩 𝐲𝐨𝐮𝐫 𝐧𝐞𝐭𝐰𝐨𝐫𝐤! #ClinicalResearch #CRCtoCRA #CareerGrowth #ClinicalTrials #ClinicalResearchAssociate #NetworkingTips #ProfessionalDevelopment #GCPCertification #ResearchSuccess #CareerTransition #CROCareers

Great list! I love it! 👍 (especially #2) I'm sure there's many more helpful things, and I'll add just one here. Practice creating patient visit source that covers every protocol requirement for that visit. Really all of them. Is your first checkbox, that you confirm whether there's a newly approved ICF that the patient needs to be reconsented to before you do anything else? Make sure that absolutely everything is in this source. Then make sure that all points on your visit source document that correspond with EDC data points appear in your source in the same order as they appear in the EDC. There will be stuff in between that needs to be in the source but does not go into the EDC. But make sure that those points that do, are in the same order as you read through the source. Maybe in bold font? Having practiced creating these kind of "perfect" source documents, and revising your templates if you notice during a visit, that something could be even more perfect will be an invaluable asset when you become a CRA. Practice creating checklists that take more time to initially set up, but eventually will save you a lot of time over the course of the study. You'll be creating the tools you need as a CRA in a similar fashion. 😉

💥 💥Seeking New Opportunities in Clinical Research Domain!💥💥 Hello, Connections! After 3+ years as a Clinical Research Coordinator, Now, I'm thrilled to explore new opportunities in the clinical research field📚    🔍What I Bring to the Table: 🚀Project Startup: Leading site analysis and budget planning. 💻Data Management: Proficient in CDM, eCRF and IWRS systems. 📃Regulatory Submissions: Efficient IRB processes for ethical and timely project starts. 🤝Collaboration: Working with sponsors, CROs, and investigators on Phase I-IV & BABE trials. 📑Audit Readiness: Successfully cleared Sponsor, QA, QC, USFDA, and DCGI audits. ⚖Compliance: High standards in AE and SAE documentation. Any leads/referrals/connections are appreciated. Let's connect and discuss potential opportunities !!!   #ClinicalResearch #JobSearch #ClinicalTrials #ResearchCoordinator #Healthcare  #Referrals #Opentowork #immediatejoiner #CRA #CRC #ClinicalData #CTA #ClinicalResearchCoordinator #ClinicalResearchAssociate

Clinical Research Associates: The Unsung Experts in Project Management Clinical Research Associate (CRA) are exceptional project managers, skillfully balancing a multitude of responsibilities to ensure the smooth execution of clinical studies. Clinical trials are complex, multifaceted projects that involve numerous stakeholders, including sponsors, regulatory bodies, clinical sites, and patients. CRAs act as the linchpin, coordinating efforts across these diverse groups. Their ability to manage timelines, resources, and communications is akin to that of a seasoned project manager. CRAs are responsible for developing and adhering to detailed project schedules. They must ensure that patient recruitment, data collection, and follow-up visits occur within the established timelines. Delays can compromise the integrity of the trial and lead to increased costs. Through meticulous planning and proactive management, CRAs keep the project on track, demonstrating exceptional time management skills. Just like project managers, CRAs must be adept at resource allocation. They oversee the use of clinical supplies, manage budgets, and ensure that financial resources are utilized efficiently. CRAs often work with tight budgets and must find ways to maximize the impact of available funds. Their ability to allocate resources effectively ensures that trials are conducted within financial constraints while maintaining high standards of quality. Effective communication is at the heart of successful project management. CRAs excel in this area, acting as the primary point of contact between sponsors, clinical sites, and regulatory authorities. The project management skills honed by CRAs transcend the clinical research field, making them valuable assets in various industries. Their expertise in coordination, time management, resource allocation, risk management, communication, and quality control is highly transferable. Whether in pharmaceuticals, biotechnology, healthcare, or other sectors, CRAs can apply their project management capabilities to ensure the successful execution of diverse projects. Their ability to navigate complex regulatory environments and maintain high standards of compliance is particularly advantageous in any industry that requires meticulous attention to detail and robust project oversight. Clinical Research Associates are not just data collectors or patient monitors; they are highly skilled project managers who navigate the complexities of clinical trials with expertise and precision. Their ability to coordinate, manage resources, mitigate risks, and ensure compliance underscores their critical role in the success of medical research. As the demand for efficient and effective clinical trials continues to grow, the project management prowess of CRAs will remain indispensable. #projectmanagement #communication #sitemanagement #deliverables #metricdriven #organization