Lead feasibility assessments, site selection, and activation for cardiology centers.
Supervise CROs, core labs, and external vendors to ensure deliverables.
Proactively track and manage project tasks against timelines using Smartsheet.
Pulse Biosciences is a novel bioelectric medicine company that develops nano-pulse technology to improve patient lives. They are a publicly traded company with a culture of innovation and collaboration, operating in a startup-like environment.
You will monitor and own the progress of clinical studies at investigative sites, ensuring studies are conducted per protocol, SOPs, ICH-GCP, and regulations.
You will coordinate all necessary activities to set up and monitor a study, including identifying investigators and preparing regulatory submissions.
You will identify potential study risks and propose solutions to mitigate them, demonstrating an impeccable eye for detail.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost, and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease, and are proud to share extremely high CRA retention rates compared to industry averages.
Conduct remote and onsite monitoring activities including Site Initiation, Interim, and Closeout Visits.
Review informed consent, source documentation, and case report forms for accuracy and completeness.
Identify, document, and escalate protocol deviations, data quality concerns, and compliance risks.
WHOOP is on a mission to unlock human performance and healthspan, empowering members to perform at a higher level through a deeper understanding of their bodies and daily lives. They are a leading wearable technology company with a collaborative and detail-oriented culture.
Serve as the site manager, ensuring data entry and query resolution, and maintain high-quality data and audit readiness at clinical sites.
Monitor ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting, both onsite and remotely.
Manage device accountability, inventory, distribution, and regulatory documentation to ensure compliance and audit readiness.
Penumbra is a global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing novel products for challenging medical conditions. The company sells its products to hospitals and healthcare providers worldwide through direct sales and distributors.
Provides leadership and strategic direction to the Site Start-up department, contributing to the expansion of people, processes, and systems.
Collaborates with cross-functional teams to secure SSU delivery and client satisfaction on activities such as regulatory submissions and site contracts.
Ensures compliance with regulatory requirements, ICH Guidelines, and Good Clinical Practices for clinical trials.
Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stages from early development through approval, with embedded experience in oncology and rare disease.
Provide strategic regulatory input and manage European Clinical Trial Applications (CTA) and amendments.
Serve as key regulatory liaison for multi-continental oncology projects, collaborating with cross-functional teams.
Maintain expertise in GCP, EU regulations, and support business development activities.
Theradex Oncology is a full-service CRO specializing in early and late-phase oncology trials globally. Founded in 1982 with over 40 years of experience, the company has managed more than 250 trials and partners with the National Cancer Institute, maintaining a focused culture on cancer drug development.
Oversee day-to-day operations of clinical trials, ensuring compliance with GCP, FDA, and ICH guidelines while managing CROs and vendors.
Serve as primary point of contact for CROs and trial vendors, tracking performance metrics, budgets, and timelines to ensure project success.
Collaborate with cross-functional teams to prioritize data integrity, participant safety, and quality control, with travel required up to 30%.
Peptilogics is a surgical therapeutics company dedicated to curing and preventing medical device-related infections. They are a clinical-stage biotech with a small, agile team and a culture of proactive, independent thinking.
Deliver clinical education and training to physicians and hospital staff during surgical study cases in the US.
Plan activities to support recruitment at sites and ensure compliance with clinical protocols and regulations.
Support multiple studies with different protocols and travel up to 70% within the Central US region.
Kuros Biosciences is a Swiss-headquartered biotech company focused on advancing bone healing with high-quality scientific evidence. With operations in the Netherlands and the USA, we continue to grow our global team and have a commercial and research footprint spanning over 20 markets.
Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.
Responsible for site monitoring of clinical trials in the Netherlands and Belgium, ensuring protocol compliance and quality.
Prepares accurate monitoring visit reports and ensures integrity of CRF data through source document review.
Provides guidance and mentorship to CRA team, assists with study budget management, and coordinates with cross-functional departments.
Alira Health is a global advisory firm providing consulting, research, and clinical development services to humanize healthcare and life sciences. With over 800 scientists, strategists, and clinicians representing 30 nationalities, they offer a vibrant environment with professional development and flexible work programs.
Provide high-level logistical support for clinical study operations, including study start-up, site management, and monitoring.
Develop and manage study-related documents such as protocols, informed consent forms, and monitoring plans.
Oversee clinical trial supplies, vendor management, and ensure compliance with regulatory requirements.
Natera is a global leader in cell-free DNA testing dedicated to oncology, women’s health, and organ health. Our team consists of highly dedicated professionals from world-class institutions who care deeply for our work and each other, working hard and growing quickly.
Oversee critical monitoring activities across clinical trials, ensuring compliance with protocols and regulations.
Collaborate with investigators and site teams to maintain study integrity and operational excellence.
Support Phase II and Phase III trials in challenging therapeutic areas to improve patient outcomes.
Jobgether uses artificial intelligence to match job seekers with opportunities through a fair and efficient process. As a growing platform, they emphasize collaboration, integrity, and patient impact in their culture.
Manage and monitor soft tissue ablation clinical trials, including site start-up, patient recruitment, and data quality.
Prepare study documents, oversee monitoring visits, and ensure compliance with FDA and ICH-GCP regulations.
Mentor other CRAs and support both U.S.-based and future international clinical studies.
Pulse Biosciences is a novel bioelectric medicine company developing the CellFX nsPFA technology for non-thermal ablation. The company is publicly traded (Nasdaq: PLSE), fosters a culture of innovation and collaboration, and is committed to hiring top talent.
Perform on-site or remote monitoring visits to ensure site adequacy for clinical studies.
Verify investigator qualifications and support regulatory submissions.
Train site staff and ensure compliance throughout the study period.
Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. They have a collaborative, international team with colleagues across the globe, valuing teamwork, flexibility, and work-life balance.
Manage clinical elements of trials including site selection, start-up, enrollment, monitoring, and close-out for studies across multiple countries.
Lead CRAs and ensure timeline adherence, quality delivery, and effective communication with cross-functional teams and sponsors.
Identify risks to project timelines, create action plans, and mentor team members while maintaining focus on study priorities.
Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, biomarker and data analytics, with a focus on rare diseases and oncology. The company is part of Precision Medicine Group, a growing organization dedicated to advancing oncology development and positively impacting patient health.
Conduct on-site or remote monitoring visits including Pre-Study, Initiation, Interim, and Close-Out activities to ensure site adequacy and compliance.
Verify investigator qualifications, resources, and facilities, and train investigational site staff as necessary.
Support regulatory submissions and mentor junior staff through co-monitoring visits and training.
Ergomed Group is a clinical research organization (CRO) that helps biopharmaceutical companies develop, deliver, and safeguard therapies in oncology, rare disease, and other complex areas. The company fosters a culture of kindness, curiosity, and a shared sense of purpose, with a diverse team of experts in clinical research, pharmacovigilance, and quality consulting.