Clinical Data Specialist - Site Operations

Iterative Health is seeking a Clinical Research Systems Specialist to help advance clinical research operations by supporting and maintaining system solutions. This position plays a key role in ensuring that clinical research management systems run smoothly and meet the needs of various teams across the organization. What you will do Work with cross-functional teams to address clinical research system requirements Implement new clinical research management systems and handle ongoing maintenance Support data integrity and compliance throughout all research activities Location This role is based in either Cambridge, Massachusetts or New York, New York.

At Iterative Health, we are at the forefront of healthcare technology and services, dedicated to revolutionizing clinical research and enhancing patient outcomes. Our Site Network is a distinguished consortium of over 70 clinical research sites across the United States and Europe, accelerating the introduction of innovative therapies in gastrointestinal (GI) and hepatology. We focus on empowering our partner sites with technology-driven services, combining extensive clinical trial expertise with cutting-edge artificial intelligence (AI), enabling research teams and sponsors to broaden and hasten access to essential therapeutics for patients.We are pioneering the integration of advanced, proprietary AI tools in cardiology and drug development, aiming to significantly enhance clinical decision-making while improving patient lives through superior diagnosis, disease management, and treatment.As a Senior Clinical Research Specialist I, you will report to the Head of Cardiology and Growth, collaborating closely with the Director of Clinical Research (Cardiology) to integrate Iterative Health’s services and AI solutions at cardiology-focused clinical research sites nationwide. This role requires exceptional communication skills, customer engagement, and comprehensive clinical research expertise, coupled with a robust strategic skill set. You will directly support a portfolio of sites by assessing their current state using our established methodologies, delivering tailored training and ongoing assistance to promote research best practices, drive the adoption of Iterative Health’s services, and ensure that our sites meet their research objectives.

Iterative Health is at the forefront of healthcare technology and services, dedicated to expediting clinical research to enhance patient outcomes. With a robust Site Network comprising over 70 clinical research sites across the United States and Europe, we specialize in accelerating the journey to market for innovative therapies in gastrointestinal (GI) and hepatology. Our mission is to foster the growth and success of our partner sites by equipping them with advanced technology-driven services. By merging extensive clinical trial expertise with pioneering AI solutions, we empower research teams and study sponsors to broaden and hasten access to crucial novel therapeutics for patients in need.About the RoleWe are on the lookout for a proactive and detail-oriented Clinical Research Finance Specialist to become a vital member of our expanding Finance team. This role entails close collaboration with the Finance Manager to oversee comprehensive accounts receivable operations related to sponsor-funded clinical studies and internal research sites.As a key player, you will manage essential transactional accounts receivable workflows, including monitoring sponsor and site-level accounts, facilitating timely collections, posting cash in RealTime CTMS, and providing invoicing support as necessary. This position demands strong collaboration with internal teams, research sites, and sponsors and CROs to guarantee precise billing, timely cash application, and swift resolution of outstanding balances.The ideal candidate will thrive in a dynamic clinical research environment, adeptly balancing hands-on execution with cross-functional teamwork and a commitment to continuous process enhancement.Key ResponsibilitiesManage daily accounts receivable operations, including monitoring sponsor and site-level balances and aiding in timely collections.Reconcile study-level balances and payment activities, identifying discrepancies and collaborating with stakeholders to resolve issues.Accurately record cash receipts and payment details in RealTime CTMS and related financial systems.Prepare and dispatch invoices for study activities and services in coordination with sponsor communications and internal teams.Professionally communicate with sponsors and CROs regarding billing inquiries, payment statuses, and outstanding balances.Assist in generating AR aging schedules, financial summaries, and internal reports.Support audits and financial reviews pertaining to accounts receivable and billing activity.Work collaboratively with Clinical Operations, Site Finance, and Accounting to clarify billing terms and deliverables.Contribute to ongoing process improvements to boost accounts receivable efficiency, accuracy, and visibility.

At Iterative Health, we are at the forefront of healthcare technology, dedicated to revolutionizing clinical research and improving patient outcomes. With a robust network of over 70 clinical research sites across the US and Europe, we expedite the journey to market for innovative gastrointestinal (GI) and hepatology therapies. Our mission is to empower our partner sites with advanced, tech-enabled services, merging extensive clinical trial expertise with state-of-the-art AI solutions, allowing research teams and study sponsors to broaden and hasten access to groundbreaking therapeutics.As a pioneering organization in applying powerful proprietary AI tools within gastroenterology, cardiology, and drug development, we aim to significantly enhance clinical decision-making, thereby improving patient lives through superior diagnostics, disease management, and treatment approaches that lead to better health outcomes.The Clinical Data Specialist plays a crucial role in our clinical trial service operations by conducting EHR chart reviews to identify suitable candidates for clinical trials.

About eGenesiseGenesis is an innovative clinical-stage biotechnology company dedicated to developing human-compatible engineered organs to tackle the critical global organ shortage. Our proprietary genome engineering platform facilitates extensive, multiplex gene edits aimed at removing major biological barriers, incorporating protective human transgenes, and inactivating endogenous retroviruses. Our flagship program, EGEN-2784, a genetically engineered porcine kidney, is currently undergoing evaluation in a multi-patient Expanded Access study at Massachusetts General Hospital (MGH). Headquartered in the vibrant city of Cambridge, MA, eGenesis is at the forefront of pioneering medical solutions.As the Lead Clinical Research Associate, you will spearhead site monitoring activities and oversee Clinical Research Associates (CRAs) for designated clinical trials. Collaborating closely with Clinical Operations leadership and cross-functional teams, you will ensure that studies are executed in strict adherence to protocols, ICH-GCP guidelines, regulatory requirements, and our company Standard Operating Procedures (SOPs).

Scholar Rock is a pioneering biopharmaceutical company dedicated to the discovery, development, and delivery of transformative therapies for patients suffering from serious diseases with significant unmet medical needs. As a global frontrunner in the understanding of the transforming growth factor beta (TGFβ) superfamily of cell proteins, Scholar Rock is aptly named for the visual resemblance of a scholar rock to protein structures. The company is currently in the clinical stage, focusing on advancing groundbreaking treatments that leverage protein growth factors to create better health outcomes. Over the past decade, Scholar Rock has cultivated a robust pipeline aimed at improving the standard of care for conditions such as neuromuscular diseases, cardiometabolic disorders, cancer, and other areas where growth factor-targeted therapies could effectuate significant change. Scholar Rock stands out as the sole company to demonstrate clinical proof of concept for a muscle-targeted treatment for spinal muscular atrophy (SMA). We are committed to pioneering fundamentally different therapeutic approaches, supported by our proprietary platform that has developed novel monoclonal antibodies capable of exquisitely modulating protein growth factors. By utilizing cutting-edge scientific advancements in disease areas that have been historically underserved by conventional therapies, Scholar Rock is dedicated to unlocking new possibilities for patients. To learn more about our innovative approach, visit ScholarRock.com and follow us on @ScholarRock and LinkedIn.Position Overview:The Medical Director/Senior Director will report directly to the Senior Vice President of Clinical Research and will play a crucial role within the late-stage development team. This individual will be responsible for overseeing the clinical development activities for product candidates, guiding them from Proof-of-Concept through to marketing approval and ongoing lifecycle management. The ideal candidate will provide medical leadership for the clinical development of apitegromab and other late-stage product candidates in accordance with the overall corporate strategy. This role requires an enthusiastic physician-scientist with substantial hands-on experience in advancing late-stage product candidates to deliver revolutionary therapies.

Join eGenesis as a Senior Clinical Research AssociateAt eGenesis, we are at the forefront of innovation in biotechnology, developing human-compatible engineered organs to combat the critical global organ shortage. Our cutting-edge genome engineering platform allows for extensive gene modifications, effectively removing biological barriers and introducing protective human transgenes. Our leading program, EGEN-2784, involves a genetically engineered porcine kidney currently under a multi-patient Expanded Access study at Massachusetts General Hospital (MGH). We are proudly headquartered in Cambridge, MA, and are dedicated to making a significant impact on healthcare.We are currently in search of a highly skilled Senior Clinical Research Associate with over 4 years of experience in monitoring intricate clinical trials within pharmaceutical, biotechnology, and CRO settings. The ideal candidate will demonstrate proven expertise in managing investigative sites, conducting site qualifications, initiation, routine monitoring (both on-site and remote), and closeout visits while ensuring adherence to ICH-GCP, regulatory requirements, and study protocols. You will be tasked with overseeing site performance, preserving data integrity through source data verification and CRF review, and maintaining timely documentation in eTMF, CTMS, and EDC systems. Additionally, you will support site start-up activities, provide training for investigators and site staff, and offer operational guidance to academic medical centers, particularly those with limited IND experience. The right candidate will possess strong capabilities in identifying operational risks, implementing effective mitigation strategies, and managing high volumes of clinical data to uphold patient safety, data quality, and study compliance. Reporting to the Lead CRA or Clinical Operations leadership, you will execute monitoring strategies and facilitate consistent oversight of assigned sites. We value collaboration and are looking for a team player who can work closely with investigative sites and cross-functional teams to enhance enrollment, address operational challenges, and ensure inspection readiness.

Iterative Health is a pioneering healthcare technology and services company dedicated to revolutionizing clinical research and enhancing patient outcomes. With an extensive network of over 70 clinical research sites in the U.S. and Europe, we are at the forefront of accelerating the market introduction of innovative gastrointestinal (GI) and hepatology therapies. Our mission is to empower our partner sites through advanced tech-enabled services, leveraging our deep expertise in clinical trials and state-of-the-art AI to broaden access to groundbreaking therapeutics for patients in need.About the RoleThe Regional Director will lead and enhance the performance of GI-focused clinical research sites within their portfolio. This role is crucial in ensuring operational excellence, aligning teams to achieve key performance metrics, elevating site capabilities, and maintaining consistency in trial execution. As a strategic leader in operations, the Regional Director will bridge site performance with overarching business objectives.ResponsibilitiesOversee staff across multiple sites, ensuring alignment with protocols, regulatory standards, and Iterative Health's guidelines.Take full ownership of site performance, encompassing recruitment, data integrity, compliance, and team culture.Ensure sites are optimally prepared for success through adequate staffing, equipment, and training, providing recommendations for resource allocation based on business needs.Foster strong partnerships with Principal Investigators (PIs) to align their engagement with study objectives and operational strategies.Influence the study portfolio to enhance profitability and patient value.Proactively identify and address issues related to site performance.Guide and develop Clinical Research Coordinators (CRCs) and site-based research personnel through clear expectations, performance coaching, and team development.Act as a visible and hands-on leader, cultivating high-performing, accountable teams.Analyze KPIs and monitor performance trends to identify and leverage factors driving site-level success.Implement corrective actions and process enhancements as necessary.Serve as the primary operational liaison between site personnel and central functions.Promote a culture of accountability, collaboration, and continuous improvement throughout all assigned sites.

Iterative Health is a leading healthcare technology and services firm dedicated to enhancing the pace of clinical research aimed at improving patient outcomes. Our Site Network comprises over 70 top-tier clinical research sites across the United States and Europe, focused on accelerating the market entry of innovative therapies in gastrointestinal (GI) and hepatology. Our mission is to ensure the success and growth of our partner sites through advanced tech-enabled services. By merging extensive clinical trial expertise with state-of-the-art AI, we empower research teams and study sponsors to broaden and hasten access to novel therapeutics for patients in need.About the RoleWe are in search of a motivated and detail-oriented Clinical Contracts Specialist to join our dynamic Legal team. In this pivotal role, you will be responsible for managing and negotiating clinical trial agreements with sponsors and biotechnology partners, serving as a vital point of contact throughout the contract lifecycle. Your organizational and communication skills, along with your commitment, will significantly influence the success of our clinical partnerships and the patients we serve.

Join our dynamic team as a Clinical Trial Leader, where you will be at the forefront of innovative clinical research. You will be responsible for overseeing the planning, execution, and management of clinical trials, ensuring compliance with all regulatory requirements and organizational standards. Your leadership will guide cross-functional teams to deliver high-quality results, contributing to the advancement of healthcare solutions.

Join Artech Information Systems LLC as a Clinical Trial Leader I. In this pivotal role, you will spearhead clinical trial operations, ensuring adherence to regulatory standards and facilitating seamless communication among cross-functional teams. Your expertise will be crucial in managing timelines, budgets, and deliverables within clinical research.

Join Integrated Resources Inc. as a Clinical Study Manager and play a pivotal role in driving groundbreaking clinical research initiatives. We are looking for a dynamic professional who excels in managing clinical trials, ensuring compliance with regulatory standards, and optimizing study protocols.Your expertise will be integral to our mission of advancing healthcare solutions and improving patient outcomes. If you're passionate about clinical research and want to make a significant impact in the industry, we encourage you to apply.

We are seeking a dedicated and detail-oriented Clinical Study Manager to oversee the planning, execution, and management of clinical studies. This role is pivotal in ensuring adherence to regulatory requirements, study protocols, and timelines. The ideal candidate will lead cross-functional teams, manage budgets, and maintain communication with stakeholders to drive the success of clinical trials.

We are seeking an experienced Clinical Trial Operations Manager to lead and oversee clinical trial activities at Artech Information Systems LLC. In this role, you will be responsible for managing the operational aspects of clinical trials, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to deliver high-quality results. Your expertise will contribute to the advancement of innovative solutions in the clinical research field.

We are seeking a dedicated and experienced Senior Clinical Study Manager to join our dynamic team in Cambridge. In this role, you will oversee the planning and execution of clinical studies, ensuring they meet regulatory standards and are completed on time and within budget. You will lead cross-functional teams and collaborate with various stakeholders to drive project success.The ideal candidate will have a proven track record in managing clinical trials, excellent communication skills, and the ability to navigate complex challenges. If you are passionate about advancing clinical research and want to make a significant impact, we encourage you to apply.

Join Integrated Resources Inc. as a Clinical Data and Analytics Lead, where your expertise will drive innovative solutions in clinical research. In this pivotal role, you will oversee the management and analysis of clinical data, ensuring accuracy and compliance with regulatory standards. Collaborate with cross-functional teams to enhance data quality and deliver actionable insights that support clinical decision-making.

We are seeking a highly skilled and motivated Clinical Operations Lead to oversee our clinical trials and operations. The ideal candidate will possess extensive knowledge of clinical research processes, ensuring that our studies are conducted efficiently and in compliance with regulatory standards. You will play a pivotal role in managing trial execution, coordinating teams, and optimizing operational strategies to drive successful outcomes.

Scholar Rock is a pioneering biopharmaceutical enterprise dedicated to the discovery, development, and delivery of transformative therapies for individuals with serious diseases that are significantly underserved. Renowned for its leadership in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins, Scholar Rock is committed to advancing innovative treatments where protein growth factors are essential. Over the last decade, the company has established a robust pipeline aimed at enhancing the standard of care for various conditions including neuromuscular diseases, cardiometabolic disorders, and cancer, where growth factor-targeted therapies can make a monumental difference. Scholar Rock stands out as the only organization to demonstrate clinical proof of concept for a muscle-targeted therapy in spinal muscular atrophy (SMA). Our dedication to exploring fundamentally novel therapeutic strategies is driven by the application of a proprietary platform that has yielded innovative monoclonal antibodies designed to modulate protein growth factors with remarkable selectivity. By leveraging advanced scientific approaches in historically neglected disease areas, Scholar Rock is committed to unlocking new opportunities for patients. Discover more about our mission at ScholarRock.com and connect with us on @ScholarRock and LinkedIn.Position Overview:The Medical Director, reporting to the VP of Clinical Research, will play a vital role in the early development team, responsible for steering clinical development initiatives for product candidates from IND to Proof-of-Concept. This role demands a highly driven physician scientist with hands-on experience in advancing product candidates aimed at delivering impactful medicines. The successful candidate will provide medical leadership for clinical development activities related to follow-on indications for apitegromab and new product candidates, aligning with corporate strategy.

As a Senior Associate for Clinical Trial Transparency at Integrated Resources, Inc., you will play a pivotal role in ensuring the integrity and transparency of clinical trial data. This position involves collaborating with clinical teams to develop and implement strategies that align with regulatory requirements and promote public trust in clinical research. You will leverage your expertise to maintain compliance and enhance the visibility of our clinical trials.