Sandy S’ Post

Hi All, Hope you all are doing good. We have an immediate opening for GA DPH Developer 3. Please share me profiles to email: sindhuja.nallamala@hrcs-llc.org. Job Title: GA DPH Developer 3 Location: Atlanta (Hybrid) Rate: $62/hr C2C Experience: 10+ Years Visa Status: Any visa (Except OPT and CPT) Job Summary: Rebuild existing TB Patient Management (TBPM) System in a modern architecture/framework. Update TB workflows to better align with TBPM processes. Eliminate the many steps involved updating various data input screens Build in processes to ingest TB eCRs and ELR data feeds Redevelop the Report of a Verified Case of TB (RVCT) process. Streamline the data extract Message Mapping Guide (MMG) for transmission to the CDC. The TBPM system is to replace the existing TBPM system built some 15 years ago, as workflows and processes have changed within the TB section, the tool used to track patients with TB hasn't kept up to date due to there not being a designated resource to keep up with these changing protocols. This has led to a system that no longer supports the day to day activities needed to be accomplished managing TB patients within Georgia. The current system has multiple tabs that split up the data entry into groups of information corresponding to the tabs heading. It is envisaged this way of organizing the various data grouping will stay the same in the rebuilt version. Current tab organization Epi Investigation - Additional Epi investigative information, genotyping, linking with a known case etc. Documents - supporting documentation upload area Imaging - Chest imaging results including type of image taken CT scan, MRI etc. Tests - Blood tests and results information with an upload function for the actual test report image. Diagnosis - Case verification status, Suspect, Not a case etc. CI - Contact Investigation Summary RVCT - This report gets built over time and once complete gets sent to the CDC. Patient - Patient Demographics, Address History etc. Assessment - Site of TB, previous diagnosis of TB and Risk factors Meds - TB Medications being taken DOT - Directly Observed Therapy and if treatment/meds stopped the reason why Susceptibility - Molecular Susceptibility Bacteriology - Drug susceptibility etc. MDR - Observes the side effects of the various prescribed medications.

we are hiring DPH developer location: atlanta, GA hybrid duration : 12+ months Job Summary: Rebuild existing TB Patient Management (TBPM) System in a modern architecture/framework. Update TB workflows to better align with TBPM processes. Eliminate the many steps involved updating various data input screens Build in processes to ingest TB eCRs and ELR data feeds Redevelop the Report of a Verified Case of TB (RVCT) process. Streamline the data extract Message Mapping Guide (MMG) for transmission to the CDC. The TBPM system is to replace the existing TBPM system built some 15 years ago, as workflows and processes have changed within the TB section, the tool used to track patients with TB hasn't kept up to date due to there not being a designated resource to keep up with these changing protocols. This has led to a system that no longer supports the day to day activities needed to be accomplished managing TB patients within Georgia. The current system has multiple tabs that split up the data entry into groups of information corresponding to the tabs heading. It is envisaged this way of organizing the various data grouping will stay the same in the rebuilt version. Current tab organization Epi Investigation - Additional Epi investigative information, genotyping, linking with a known case etc. Documents - supporting documentation upload area Imaging - Chest imaging results including type of image taken CT scan, MRI etc. Tests - Blood tests and results information with an upload function for the actual test report image. Diagnosis - Case verification status, Suspect, Not a case etc. CI - Contact Investigation Summary RVCT - This report gets built over time and once complete gets sent to the CDC. Patient - Patient Demographics, Address History etc. Assessment - Site of TB, previous diagnosis of TB and Risk factors Meds - TB Medications being taken DOT - Directly Observed Therapy and if treatment/meds stopped the reason why Susceptibility - Molecular Susceptibility Bacteriology - Drug susceptibility etc. MDR - Observes the side effects of the various prescribed medications. Skill Required / Desired Amount of Experience Bachelor's Degree from an accredited college or university with coursework in Computer Science or management systems.Required  TB Patient Management (TBPM) SystemRequired6YearsUpdate TB workflows to better align with TBPM processesRequired6YearsBuild in processes to ingest TB eCRs and ELR data feedsRequired6YearsStreamline the data extract Message Mapping Guide (MMG) for transmission to the CDCRequired6Years please reach me at anil@khpsolutions.com or +1 469-277-7093 #dph #developer #c2c #w2 #2024jobs

ALCOA+ is a set of principles that ensures the trustworthiness of data collected in clinical trials. Imagine you're a detective investigating a crime scene - ALCOA+ is like your checklist to make sure all the evidence is reliable. Here's a breakdown with a clinical trial example: ALCOA (original principles): Attributable: Who did it? In a trial, all data entries need to be traceable to a specific person (investigator, nurse, etc.) with a date and time stamp. This is often done electronically with user logins and timestamps. Legible: Can you read it clearly? Data should be clear and easy to understand, avoiding abbreviations or handwriting that might be misinterpreted. Electronic records with defined formats ensure legibility. Contemporaneous: Write it down when it happens! Observations and measurements should be documented at the time they occur, minimizing the risk of forgetting details later. Original or Accurate Copy: Is it the real deal? The data should be the original source or a verified copy that hasn't been tampered with. Imagine the detective using a certified copy of a fingerprint, not a blurry photo. Accurate: Is it true? The data needs to be a true reflection of what happened. This involves double-checking entries and comparing them to source documents like patient charts. ALCOA+ (additional principles): Complete: Does it answer all the questions? The data should be comprehensive, including details like who, what, when, where, why, and how. Consistent: Is the story straight? Data entries throughout the trial should follow the same format and definitions to avoid confusion. Enduring: Will it last? The data needs to be stored securely in a way that can be accessed and reviewed for a long period, even after the trial is complete. Available: Can you find it when you need it? The data should be readily accessible to authorized personnel for review and analysis. Example: Imagine a nurse is recording a patient's blood pressure during a trial for a new medication. Following ALCOA+, the nurse would: Attributable: Log in to the electronic data capture (EDC) system with their unique ID. Legible: Enter the blood pressure reading using a pre-defined format (e.g., 120/80 mmHg). Contemporaneous: Take the reading and enter it immediately after measuring the patient's blood pressure. Original or Accurate Copy: The EDC system ensures the data is an accurate reflection of the reading on the blood pressure cuff. Accurate: Double-check the reading for any typos. By following ALCOA+, clinical data managers can ensure the information collected is reliable and trustworthy, leading to more meaningful results from clinical trials.

2024 has been an incredible year for biotech so far, with many of our clients reaching long-awaited approvals and experiencing unprecedented growth. Unfortunately, others had incurred layoffs and restructuring, which left many talented candidates in search of new roles.   My team and I worked with each of these individuals for many years and can personally vouch not only for their skills but for their great human qualities and the incredible value they brought to their employers. If any of the folks below fit your current or future hiring needs, please reach out to me and I'll connect you to them.   Say "Hello" to your next best hire! Director of Statistical Programming (placed by us in the past) - 20 years of experience, great people leader, but hands-on when needed (recently integrating R and Python into their SAS team) - sponsor side experience (Oncology, Women’s Health, Neurology, Rare Disease, etc.)   AD/Director of Statistical Programming (have known for 10+ years) - 25 years of experience, primarily within a CRO (also FSP) - feels her strength lies in operational and people leadership as well as process improvements, but happy to do hands-on programming also   Clinical Data Manager (have known for 5+ years) - over 8 years of experience, hands-on & leadership skills (had 5 direct reports) - worked across all phases of clinical trials (oncology, cardiovascular, immunology, respiratory, CNS, etc.) Contract Principal SAS Programmer (referred to us and recommended by a trusted Hiring Manager we placed) - over 20 years of experience - currently a lead programmer focused on Efficacy, ISE analysis and responsible for graphics programming in addition to tables and listings - strong experience with NDA submissions and solid macro development as well   Director/Executive Director of Biometrics (have known for 5+ years) - PhD in Statistics and nearly 20 years of sponsor-side experience in various TAs including Oncology, CNS, Immunology, Hematology, etc. - experience building and leading teams of programmers, Biostatisticians, and Data Managers - not just a people leader but a key contributor to trial design   Associate Director, Clinical Data Management (placed by us multiple times) - over 16 years of DM experience, both hands-on and managerial - extensive CRO oversight as well as leading onsite DM teams and responsibilities   Principal/ Lead Data Manager (placed by us before) - over 15 years of Data Management experience with big pharma as well as small/midsize biotech - extensive experience in CRO/vendor Oversight - CDM experience from study start-up to close-out 

As mentioned on my Linked In profile, I was once an APEX CRA and then transitioned gracefully into the CRA I role through this program. I can personally confirm that this program was nothing short of an amazing opportunity for someone looking to start or further their career in research. Please refer to the post below for more details on how to apply to the program to be apart of the April 2024 cohort!

#hiring Physician / Hematology / Texas / Permanent / Hematology Opening, Houston, Texas Job, Houston, United States, fulltime #jobs #jobseekers #careers #Houstonjobs #Texasjobs #HealthcareMedical Apply: https://lnkd.in/g8sqyTY2 Hematology OpportunityHouston, TX more information on this Hematology opening and others like it through Metropolis, a Provider Engagement Platform that connects you with organizations in the top 100 Metropolitan areas. Metropolis sources physicians according to each organization's search parameters in a secure, hands-off environment where you can passively or actively evaluate available openings. Metropolis is designed to be user friendly, as it requires very little oversight, offers 24/7 updates on openings without being bombarded by recruiters, and can be easily accessed via laptop, smart phone, or smart device. Unlike traditional job boards, Metropolis offers a confidential experience for both the healthcare facilities and the candidatesMetropolis does not allow recruiting firms on the platform and only shares your information if an organization matches your specific preferences. Additionally, you have the ability to omit facilities you dont want to match with. Lastly, Metropolis operates off sincerity and integrity; job postings will never claim a job is located in the city when it is actually over an hour away.Im already set to interview! I really like Metropolis and love the direct connection to the organization! Jacksonville CandidateGo to the link below to get connected with Hematology openings!

🌟 Three essential Clinical Monitoring Plan (CMP) components that all CRAs should prioritize for a clinical study! 🌟 🔍Here are three of the crucial Clinical Monitoring Plan (CMP) components that Clinical Research Associates (CRAs) should prioritize to ensure the integrity and quality of your clinical study. These aspects play a vital role in ensuring the success and integrity of clinical trials.📝📊 1️⃣ Site Monitoring Visit Strategy: Effective site monitoring visits are the backbone of successful clinical trials. CRAs must focus on developing a robust monitoring visit strategy. This includes pre-planning activities, such as reviewing essential documents and site feasibility assessments. During on-site visits, CRAs should closely collaborate with investigators and study coordinators, conducting source data verification, assessing compliance, and ensuring protocol adherence. Regular and timely monitoring visits promote data quality, patient safety, and clinical trial integrity. 2️⃣ Data Entry and Query Resolution Strategy: Accurate and complete data collection is paramount for clinical trials. CRAs should emphasize the development of a robust data entry and query resolution strategy. This involves training site staff on proper data entry practices, ensuring appropriate data collection tools, and implementing a comprehensive data management system. Timely query resolution is crucial to maintain data integrity. CRAs are pivotal in identifying and resolving data discrepancies through effective communication and collaboration with site staff and data management teams. 3️⃣ Safety Reporting Strategy: Patient safety is paramount in clinical trials. CRAs need to prioritize the implementation of a robust safety reporting strategy. This entails working closely with investigators and site staff to ensure adverse events (AEs) and serious adverse events (SAEs) are promptly reported, documented, and appropriately managed. CRAs must ensure compliance with regulatory requirements, facilitate safety data collection, and monitor the overall safety profile of the trial. Timely and accurate safety reporting contributes to patient welfare and regulatory compliance. ➡️👓By focusing on these three aspects—site monitoring visit strategy, data entry and query resolution strategy, and safety reporting strategy—CRAs can significantly contribute to the success of clinical trials, maintaining data integrity, patient safety, and regulatory compliance. 💡If you're in clinical research, I'd love your thoughts on these critical aspects! Comment and share your insights and this post with your fellow clinical research professionals aspiring to reach new heights in their careers. 👥💼. #HowtoSnagthatSrCRAJob #ClinicalResearch #ClinicalTrials #ClinicalMonitoring #PatientSafety  #DataIntegrity #RegulatoryCompliance #SeniorCRA #IndustryInsights #CareerDevelopment #ProfessionalDevelopment #ClinicalMonitoringPlan #GoodClinicalPractice #CRACareerDevelopment

🌟 Three essential Clinical Monitoring Plan (CMP) components that all CRAs should prioritize for a clinical study! 🌟 🔍Here are three of the crucial Clinical Monitoring Plan (CMP) components that Clinical Research Associates (CRAs) should prioritize to ensure the integrity and quality of your clinical study. These aspects play a vital role in ensuring the success and integrity of clinical trials.📝📊 1️⃣ Site Monitoring Visit Strategy: Effective site monitoring visits are the backbone of successful clinical trials. CRAs must focus on developing a robust monitoring visit strategy. This includes pre-planning activities, such as reviewing essential documents and site feasibility assessments. During on-site visits, CRAs should closely collaborate with investigators and study coordinators, conducting source data verification, assessing compliance, and ensuring protocol adherence. Regular and timely monitoring visits promote data quality, patient safety, and clinical trial integrity. 2️⃣ Data Entry and Query Resolution Strategy: Accurate and complete data collection is paramount for clinical trials. CRAs should emphasize the development of a robust data entry and query resolution strategy. This involves training site staff on proper data entry practices, ensuring appropriate data collection tools, and implementing a comprehensive data management system. Timely query resolution is crucial to maintain data integrity. CRAs are pivotal in identifying and resolving data discrepancies through effective communication and collaboration with site staff and data management teams. 3️⃣ Safety Reporting Strategy: Patient safety is paramount in clinical trials. CRAs need to prioritize the implementation of a robust safety reporting strategy. This entails working closely with investigators and site staff to ensure adverse events (AEs) and serious adverse events (SAEs) are promptly reported, documented, and appropriately managed. CRAs must ensure compliance with regulatory requirements, facilitate safety data collection, and monitor the overall safety profile of the trial. Timely and accurate safety reporting contributes to patient welfare and regulatory compliance. ➡️👓By focusing on these three aspects—site monitoring visit strategy, data entry and query resolution strategy, and safety reporting strategy—CRAs can significantly contribute to the success of clinical trials, maintaining data integrity, patient safety, and regulatory compliance. 💡If you're in clinical research, I'd love your thoughts on these critical aspects! Comment and share your insights and this post with your fellow clinical research professionals aspiring to reach new heights in their careers. 👥💼. #HowtoSnagthatSrCRAJob #ClinicalResearch #ClinicalTrials #ClinicalMonitoring #PatientSafety  #DataIntegrity #RegulatoryCompliance #SeniorCRA #IndustryInsights #CareerDevelopment #ProfessionalDevelopment #ClinicalMonitoringPlan #GoodClinicalPractice #CRACareerDevelopment

🌟 Three essential Clinical Monitoring Plan (CMP) components that all CRAs should prioritize for a clinical study! 🌟 🔍Here are three of the crucial Clinical Monitoring Plan (CMP) components that Clinical Research Associates (CRAs) should prioritize to ensure the integrity and quality of your clinical study. These aspects play a vital role in ensuring the success and integrity of clinical trials.📝📊 1️⃣ Site Monitoring Visit Strategy: Effective site monitoring visits are the backbone of successful clinical trials. CRAs must focus on developing a robust monitoring visit strategy. This includes pre-planning activities, such as reviewing essential documents and site feasibility assessments. During on-site visits, CRAs should closely collaborate with investigators and study coordinators, conducting source data verification, assessing compliance, and ensuring protocol adherence. Regular and timely monitoring visits promote data quality, patient safety, and clinical trial integrity. 2️⃣ Data Entry and Query Resolution Strategy: Accurate and complete data collection is paramount for clinical trials. CRAs should emphasize the development of a robust data entry and query resolution strategy. This involves training site staff on proper data entry practices, ensuring appropriate data collection tools, and implementing a comprehensive data management system. Timely query resolution is crucial to maintain data integrity. CRAs are pivotal in identifying and resolving data discrepancies through effective communication and collaboration with site staff and data management teams. 3️⃣ Safety Reporting Strategy: Patient safety is paramount in clinical trials. CRAs need to prioritize the implementation of a robust safety reporting strategy. This entails working closely with investigators and site staff to ensure adverse events (AEs) and serious adverse events (SAEs) are promptly reported, documented, and appropriately managed. CRAs must ensure compliance with regulatory requirements, facilitate safety data collection, and monitor the overall safety profile of the trial. Timely and accurate safety reporting contributes to patient welfare and regulatory compliance. ➡️👓By focusing on these three aspects—site monitoring visit strategy, data entry and query resolution strategy, and safety reporting strategy—CRAs can significantly contribute to the success of clinical trials, maintaining data integrity, patient safety, and regulatory compliance. 💡If you're in clinical research, I'd love your thoughts on these critical aspects! Comment and share your insights and this post with your fellow clinical research professionals aspiring to reach new heights in their careers. 👥💼. #HowtoSnagthatSrCRAJob #ClinicalResearch #ClinicalTrials #ClinicalMonitoring #PatientSafety  #DataIntegrity #RegulatoryCompliance #SeniorCRA #IndustryInsights #CareerDevelopment #ProfessionalDevelopment #ClinicalMonitoringPlan #GoodClinicalPractice #CRACareerDevelopment

#hiring Physician / Hematology / Nebraska / Permanent / Hematology Opening, Omaha, Nebraska Job, Omaha, United States, fulltime #jobs #jobseekers #careers #Omahajobs #Nebraskajobs #HealthcareMedical Apply: https://lnkd.in/g8t9tN2e Hematology OpportunityOmaha, NE more information on this Hematology opening and others like it through Metropolis, a Provider Engagement Platform that connects you with organizations in the top 100 Metropolitan areas. Metropolis sources physicians according to each organization's search parameters in a secure, hands-off environment where you can passively or actively evaluate available openings. Metropolis is designed to be user friendly, as it requires very little oversight, offers 24/7 updates on openings without being bombarded by recruiters, and can be easily accessed via laptop, smart phone, or smart device. Unlike traditional job boards, Metropolis offers a confidential experience for both the healthcare facilities and the candidatesMetropolis does not allow recruiting firms on the platform and only shares your information if an organization matches your specific preferences. Additionally, you have the ability to omit facilities you dont want to match with. Lastly, Metropolis operates off sincerity and integrity; job postings will never claim a job is located in the city when it is actually over an hour away.Im already set to interview! I really like Metropolis and love the direct connection to the organization! Jacksonville CandidateGo to the link below to get connected with Hematology openings!