Act as the primary clinical expertise within SGS Medical Device certification activities.
Review and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations.
Develop, update and maintain appropriate training packages (with a focus of clinical evaluation assessments) for clinical experts and clinical specialists.
Conduct and report all types of onsite monitoring visits as well as remote visits.
Perform CRF review, source document verification and query resolution.
Be responsible for site communication and management.
PSI is a dynamic, global, mid-size company founded in 1995, bringing together more than 3,000 driven, dedicated, and passionate individuals. They work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Support sites participating in clinical trials for the Cara System, including installation, case support, and data collection.
Be accountable for day-to-day operations of the study(ies), ensuring adherence to study protocol, ICH/GCP, and other applicable regulations.
Cara Medical is a rapidly growing “Software as Medical Device” startup. They develop an innovative solution to noninvasively visualize the cardiac conduction system and personalizes and optimizes pacing and structural heart procedures.
Proctor cases to excellence and independently cover CVAC procedures, training the surgical team on the safe and effective uses of the device.
Work closely with the surgical team members to provide clinical product assistance to the surgeon by being familiar with the surgical procedure, instruments, supplies, and equipment.
Train the surgical team on instrument preparation prior to cases and during the surgical procedure, and manage inventory needs in the account and any accompanying administrative requirements.
Calyxo, Inc. is a medical device company that addresses the profound need for improved kidney stone treatment. Founded in 2016 and headquartered in Pleasanton, California, they are led by executives and investors with a proven track record of commercializing paradigm-shifting devices.
Lead development and execution of global regulatory strategy.
Act as a subject matter expert in regulatory affairs for product introduction.
Participate in quality system and design dossier audits.
Jobgether is a platform that helps candidates get jobs by using AI-powered matching process. They appear to be a medium-sized company that values speed, objectivity, and fairness in their application review process.
Act as the lead clinical liaison for partner providers across multiple regions
Advocate for the clinical value of care models and address provider inquiries
Stay updated on regulatory standards to ensure compliant, high-quality care
Jobgether uses an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Their system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company.
Lead the development and implementation of regulatory and quality assurance strategies.
Coach and develop a small, hands-on Quality Assurance and Regulatory Affairs team.
Act as an internal SME (Subject Matter Expert) on regulatory requirements.
Ada envisions a world where everyone gets the healthcare they need, using AI and a team of physicians and clinical scientists to help people get answers faster. If you’re passionate about transforming healthcare and ensuring no one goes undiagnosed, join Ada.
Act as a strategic advisor to internal Solventum teams on clinical strategy and industry best practices.
Present compelling data and clinical application during priority planned customer engagements.
Engage alongside local teams to plan & lead comprehensive customer education events.
Solventum is a healthcare company, newly formed from 3M, dedicated to solving challenges that improve lives and enable healthcare professionals. They are focused on innovations at the intersection of health, material, and data science, with a legacy built upon empathy and clinical intelligence.
Monitor the progress of clinical studies at investigative sites, ensuring studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate activities to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Identify potential study risks and propose solutions on how to mitigate them.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve therapies for patients, with a focus on Oncology and Rare Disease. They cultivate a culture, and have high CRA retention rates.
Assist with investigator recruitment activities and site feasibility tasks.
Perform essential document collection, review, and maintenance activities.
Act as site contact for study and site management issues.
Precision for Medicine supports life sciences companies in the use of precision medicine by helping them design and execute clinical trials. They focus on biomarker-led strategies and have expertise in data science, clinical trial management, and laboratory services.
Enroll and revalidate doctors and facilities with payors.
Process applications for licensing, permits, certifications, insurances, and relevant credentialing documents.
Review incoming insurance correspondence and mail and maintain and update credentialing spreadsheets accordingly.
CHOICE is the largest provider of pediatric dental care in the Southwest United States. They pride themselves on delivering high quality care to children in their communities.
Proctor cases to excellence and independently cover CVAC procedures, training the surgical team.
Provide clinical product assistance to the surgeon by being familiar with the surgical procedure.
Manage inventory needs in the account and any accompanying administrative requirements.
Calyxo, Inc. is a medical device company that addresses the profound need for improved kidney stone treatment. The company was founded in 2016 and is led by executives and investors with a proven track record of commercializing paradigm-shifting devices.
Proactively source, engage, and nurture passive SLP and clinician candidates across priority markets.
Develop and refine outreach messaging, sequencing, and engagement strategies to improve response and conversion rates.
Partner cross-functionally to strengthen sourcing strategy and refine Expressable’s clinician value proposition.
Expressable is a virtual speech therapy practice that aims to transform care delivery and expand access to high-quality services. They have served thousands of clients since 2019 and are passionate advocates of parent-focused intervention, setting a new standard in speech therapy.
Oversight of site level tasks associated with efficient site activation.
Support the CRA team in preparing for site initiation visits (SIVs).
Perform initial contract and budget negotiations with the sites, as well as amended where applicable
Fortrea helps to turn the impossible into I'm possible. They deliver exceptional service to their patients, fueled by a shared commitment to teamwork and excellence.
Responsible for timely and quality delivery of site activation readiness, mitigating risks.
Prepare Clinical Trial Application Forms and submission dossiers for regulatory bodies.
Maintain project plans, trackers, and regulatory intelligence tools.
Precision for Medicine is a Clinical Research Organization with an integrated offering that combines clinical trial designs, operational and medical experts, and biomarker and data analytics solutions. They have a passion for rare diseases and oncology, and are growing their team.
Assist with case abstraction under the direction of a Team Leader
Complete assigned abstractions in a timely manner
Roles and responsibilities often evolve and adapt over time.
Layer Health was founded in 2023 by leading machine learning researchers from MIT and Harvard Medical School. They are building an AI layer to synthesize information from medical records and reduce friction in healthcare; their LLM-powered platform solves chart review. The diverse founding team brings expertise across machine learning, UI/UX, large language models, and medicine.
Facilitating negotiations of site agreements and budgets to ensure alignment with the site activation plan.
Customizing and preparing country- and site-specific agreements and organizing their translations.
Tracking the status of site agreement and budget negotiation.
They are a company that cares for their staff, clients, partners and the quality of their work. A dynamic, global company founded in 1995, they bring together more than 3000 driven, dedicated and passionate individuals, working on the front line of medical science, changing lives, and bringing new medicines to those who need them.
Work with the Clinical Sales Manager to develop a strategy to drive utilization of the daVinci Surgical System.
Become a da Vinci Surgery expert across all primary surgical specialties to support the development of surgical robotics programs.
Support regional Sales and Marketing development events that create system awareness and procedure adoption.
Intuitive Surgical is a global leader in robotic-assisted surgery and minimally invasive care. Their technologies, like the da Vinci surgical system and Ion, have transformed how care is delivered for millions of patients worldwide. They are a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human.
Own the day-to-day tracking and progress of clinician credentialing and payer enrollment workflows.
Identify and resolve blockers across credentialing, enrollment, and re-credentialing processes.
Support clinicians directly by guiding them through credentialing and enrollment requirements.
Wheel is evolving the traditional care ecosystem by equipping companies with a premier platform to deliver virtual care at scale. They offer strategies and technologies to foster consumer engagement, build brand loyalty, and maximize return on investment.
Responsible for delivery of site activation readiness within the assigned country/sites.
Preparation of Clinical Trial Application Forms and submission dossier for submission to CA, EC, and other applicable local bodies.
Act as SME for collection and maintenance of site level critical path to Site Activation data points.
Precision Medicine Group is an organization that works in the medical field. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Complete timely review of healthcare services using appropriate medical criteria to support determinations.
Document clinical findings and rationale clearly and accurately in accordance with federal/state regulations, URAC standards, and Guidehealth policies.
Communicate precertification and concurrent review decisions—verbally and in writing—to required parties within defined timeframes.
Guidehealth is a data-powered, performance-driven healthcare company dedicated to operational excellence. Driven by empathy and powered by AI and predictive analytics, Guidehealth leverages remotely-embedded Healthguides™ and a centralized Managed Service Organization to build stronger connections with patients and providers.