Senior Associate for Clinical Trial Transparency

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).

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.

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.

We are seeking a highly skilled and motivated Contract Clinical Operations Lead to join our dynamic team. In this pivotal role, you will oversee clinical trial operations, ensuring adherence to regulatory requirements and best practices. Your expertise will guide project management, resource allocation, and team coordination, driving the successful execution of clinical studies.

We are seeking a talented and driven Clinical Data and Analytics Lead to join our dynamic team in Cambridge, MA. This role will be pivotal in overseeing the collection, management, and analysis of clinical data to ensure the highest quality of insights and analytics. You will collaborate with cross-functional teams to develop data solutions that drive strategic decisions and improve patient outcomes.The ideal candidate will have a strong background in clinical data management, proven analytical skills, and a passion for leveraging data to enhance healthcare delivery. If you are ready to make a significant impact in the field of clinical analytics, we want to hear from you!

We are seeking a dedicated and experienced Clinical Operations Lead to oversee and enhance our clinical operations. In this pivotal role, you will be responsible for ensuring that our clinical trials are executed efficiently and in compliance with regulatory standards. You will collaborate closely with cross-functional teams to streamline processes, improve patient care, and deliver high-quality results.

Integrated Resources Inc. is seeking an experienced Clinical Operations Lead to join our dynamic team in Cambridge, Massachusetts. This pivotal role involves overseeing clinical trial operations, ensuring compliance with regulatory standards, and leading cross-functional teams to achieve project milestones. The ideal candidate will have a strong background in clinical research and a passion for advancing healthcare solutions.

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.

Join Integrated Resources, Inc. as a Pharmaceutical Research Associate, where you will play a vital role in advancing medical research and drug development. You will collaborate with a team of scientists and researchers to assist in the design and execution of clinical trials, ensuring the integrity and accuracy of data collection.Your contributions will help pave the way for innovative therapies that make a difference in patients' lives. Ideal candidates are detail-oriented, possess strong analytical skills, and have a passion for the pharmaceutical industry.

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.

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.

We are seeking a detail-oriented and motivated Research Associate to join our dynamic team at Integrated Resources, Inc. As a Research Associate, you will play a pivotal role in conducting research, analyzing data, and supporting various projects that contribute to the advancement of our organization’s goals.Your responsibilities will include collaborating with cross-functional teams, preparing reports, and presenting findings to stakeholders. This position offers an excellent opportunity for professional growth and development in a fast-paced environment.

Join our team at Integrated Resources Inc. as an Associate Research Scientist, where you will contribute to cutting-edge research projects that impact real-world applications. We are looking for passionate individuals eager to innovate and collaborate in a dynamic environment. In this role, you will support senior scientists in the design and execution of experiments, analyze data, and contribute to publications. This is a fantastic opportunity to grow your career in scientific research.

We are seeking a highly skilled Clinical Operations Lead to join our dynamic team. In this pivotal role, you will oversee the management of clinical operations to ensure efficient execution of clinical studies. Your expertise will be instrumental in driving the strategic direction of our clinical programs and leading cross-functional teams to achieve project objectives.

We are seeking a highly motivated Senior Research Associate to join our dynamic team at Integrated Resources, Inc. In this pivotal role, you will conduct advanced research, analyze data, and contribute to innovative projects that drive our mission forward. If you are passionate about scientific research and eager to make an impact, we want to hear from you!

We are seeking a talented and dedicated Senior Research Associate to join our dynamic team in Cambridge. In this role, you will contribute to innovative research projects and collaborate with interdisciplinary teams to drive impactful findings.

We are seeking a highly skilled and experienced Senior Clinical Operations Lead to join our dynamic team in Cambridge. As a pivotal member of our clinical operations team, you will play a critical role in overseeing the planning, execution, and management of clinical trials. Your expertise will ensure adherence to regulatory standards and best practices, while also fostering collaboration across multidisciplinary teams.Your responsibilities will include developing operational strategies, managing budgets, and ensuring timely project delivery. You will also be responsible for mentoring junior staff and facilitating training programs.

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.