Clinical Research Analyst

Clinical Research Analyst Location: Onsite - Origin Medical Research Lab, 644, 12th Cross Road, HSR Layout, Bengaluru, Karnataka 560102 Team: Clinical Research  Job Type: Full-Time  Skills: Clinical trials and studies design and management, Technical writing, Analyzing clinical research papers Origin Medical Research Lab seeks highly talented and self-motivated individuals ready to build impactful products to democratize quality prenatal care globally for every expecting mother. At Origin Medical Research Lab, we offer an empowering work environment that allows you to take full ownership of your work and fosters collaboration and personal growth. We look for exceptional individuals and outliers who want to join us on this mission. Embark on a purpose-driven career journey by joining our team. About Origin Medical Research Lab Origin Medical Research Lab is the research arm of Origin Medical. Here, we strive to bring together the best and brightest minds at the intersection of AI and healthcare to fulfill Origin Medical’s mission.  By combining the knowledge of healthcare and AI, it is on a journey to build state-of-the-art solutions aimed at supporting a broad spectrum of healthcare providers in rural and urban communities, allowing them to practice at the top of their licenses. With AI in the imaging workflow, clinicians can more confidently deliver timely interventions, enhance pregnancy outcomes, identify high-risk pregnancies to reduce maternal mortality, and significantly lower infant mortality rates. Origin Medical, headquartered in Cambridge, Massachusetts, USA, is driven by a mission to advance maternal health equity by improving access to quality prenatal care with artificial intelligence. About Clinical Research Team and the Role The Clinical Research team acts as a liaison between the internal teams (clinical, engineering, product, regulatory), clinical investigators, and potentially conflicting worlds of regulators and government bodies to help make sure that marketed products are safe and effective when used on expecting mothers and their babies. This is achieved through planning, designing, executing, and monitoring necessary clinical studies to ensure the highest standards of technology and product safety at all times. We ensure Good Clinical Practices (GCP) conformance in alignment with the current regulatory practices for the clinical studies that take place in the organization along the various stages of the product development life cycle. Our aim is to foresee the impact of ever-changing clinical regulations that would affect the organization’s compliance policies and reflect those for conforming to current guidelines and practices. What will you do? As a Clinical Research Analyst, you will play a key role by closely working with the Regulatory Affairs team, and renowned regulatory and clinical trial experts and consultants for planning, designing, and executing clinical studies and trials required for FDA clearance of our flagship product and ensure adherence to international regulations and guidelines. You will also be responsible to conduct clinical studies and coordinate with the clinical, product, and engineering teams (AI, software, data) to analyze clinical data and results periodically along the product development life cycle to monitor safe and effective technology development. Clinical trials and studies design and management: Conduct clinical studies by coordinating with clinical principal investigators and contract research organizations, and coordinate with the research team to analyze clinical data and results from the study team to benchmark and perform appropriate statistical assessments. Ensure technology safety and efficacy: Liaise with clinicians, internal team comparison of data engineers, and research engineers for preparing appropriate datasets for clinical studies to ensure the safety and effective functioning of the product. Clinical site management: Develop strategies to select the relevant clinical sites , setting up the trial sites, which includes training the site staff to trial-specific industry standards, monitoring the trial throughout its duration from a Medical/Scientific/Clinical perspective, which involves visiting the trial sites on a regular basis. Technical writing: Preparing technical documents to support implementing good clinical practices, filing and collating trial documentation and reports, assisting in preparing clinical trial site ethics review board applications for investigational device trials, prepare interim or final reports for trial site ethics boards as required. Documentation of current regulations: Have a close eye on changes in GCPs and immediately document the change in device regulations. Document management: Maintain and update all the clinical studies documents and regulatory documentation related to clinical studies, wherever and whenever necessary. Interaction with clinical investigators: Liaising with investigators on the conduct of the trial. Device comparable research: Develop strategies and search for clinical studies of technically similar devices in the market of interest for commercialization. Who are we looking for? Highly motivated individuals looking for building a career in clinical research and trials that are essential to bringing any medical device out in the market for improving the lives of people and quality of care. Individuals who are passionate about medical AI and are keen to work across all the teams during every stage of medical AI product development, to ensure the product’s safety and effective functioning of the technology. A detail-oriented individual who can efficiently design, manage, and conduct clinical studies. An individual who is inquisitive and has the ability to self-learn new skills or techniques needed. Good written and verbal communication skills with the ability to listen, articulate, and advocate. Proactive, high-performance, result-oriented, and manage projects with ethical integrity. Technical research and documentation skills (e.g. analyzing clinical research papers, preparing internal policies and documentation on Microsoft 365 applications). Knowledge of statistical programming software and languages like SPSS, R, or Python is a plus. Manage multiple projects and deadlines. Ability to identify compliance risks and escalate when necessary. Working at Origin Medical Research Lab You will receive competitive monthly compensation aligned with industry standards. Additionally, we provide a comprehensive benefits package, including:  Provident fund, Paid annual leaves, Sick leaves, Wellness allowance, Insurance allowance You will work with an exceptional team of highly qualified individuals who strive towards a common goal of delivering a product that improves the standard of care for expecting mothers everywhere.  You will also collaborate with renowned clinicians, AI scientists, and business leaders from around the world. At Origin Medical Research Lab, we take pride in fostering an inclusive and optimistic company culture that places great value on collaboration, teamwork, and work-life balance. As a valued member of our team, you will have the opportunity to join a supportive environment where individuals genuinely care about each other's success and well-being. Our dedicated colleagues are always ready to lend a helping hand and wish you nothing but the best in your professional journey.