Responsible for preparing and submitting clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manages site start-up activities including essential document collection, informed consent form review, and coordination with investigators and contracts.
Acts as a subject matter expert for regulatory submissions and may support process improvement, training, and mentoring.
Precision for Medicine is a clinical research organization (CRO) that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed and success rate of bringing therapies to patients, with a focus on Oncology and Rare Disease. It is a growing company with a culture of innovation and collaboration.
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.
Lead the study start-up process, developing strategy and coordinating regulatory deliverables to meet targets.
Serve as primary contact for start-up activities, prepare and review regulatory documents, and ensure compliance with ICH-GCP and regulations.
Manage essential document collection, site correspondence, contract negotiations, and support team training and budget monitoring.
Ergomed is a mid-sized contract research organization specializing in oncology and rare disease. The company has a global presence with operations in Europe, North America, and Asia, and emphasizes employee well-being, work-life balance, and career development.
Act as a strategic partner for key customers, leading governance, growth initiatives, financial performance, and cross-functional collaboration.
Lead and oversee global, multiregional, or complex regional Clinical FSP partnerships, ensuring alignment with contractual agreements and strategic priorities.
Provide executive oversight for clinical FSP delivery, ensuring quality, timelines, key performance indicators, and contractual commitments are achieved.
The employer is a global clinical research organization that partners with pharmaceutical and biotech companies to deliver clinical trials. They are a large, established company with a culture focused on innovation, collaboration, and advancing healthcare worldwide.
Support feasibility and study start-up activities for clinical research sites in Romania and Moldova, coordinating documents and site communication.
Maintain accurate trackers in Salesforce and Asana, flagging blockers and delays early to ensure timely site activation.
Serve as a day-to-day operational contact for sites, routing questions to appropriate internal, CRO, or sponsor contacts.
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The company has 250+ employees worldwide and is headquartered in Cambridge, Massachusetts, and New York City, with a collaborative and low-ego team environment.
Provide regulatory advice and ensure compliance with U.S. regulations and ICH GCP guidelines for clinical research sites.
Coordinate IRB submissions, maintain regulatory documentation, and support site start-up and close-out activities.
Collaborate with cross-functional teams and monitor regulatory changes to advise stakeholders.
Care Access is working to make the future of health better for all by bringing world-class research and health services directly to communities that often face barriers to care. With hundreds of research locations, mobile clinics, and clinicians across the globe, the company is dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Monitor and own the progress of clinical studies at investigative sites.
Ensure studies are conducted per protocol, SOPs, ICH-GCP, and all applicable regulations.
Coordinate setup activities including investigator identification and regulatory submissions.
Precision for Medicine is a CRO integrating clinical trial execution with scientific and lab expertise, focusing on Oncology and Rare Disease. They have a strong culture with high CRA retention and emphasize work-life balance.
Manage complex regulatory activities related to active pharmaceutical ingredients, including DIFA/DMF processes and lifecycle management.
Provide strategic guidance and risk management support for API documentation and supplier qualification.
Collaborate with multidisciplinary teams and external partners to ensure regulatory compliance and operational excellence.
The partner company is a player in the pharmaceutical industry, focusing on regulatory affairs and lifecycle management of innovative products. The team size and culture are not specified, but the role emphasizes collaboration, continuous improvement, and remote work based in Brazil.
Manage day-to-day regulatory affairs support, including clinical trial applications and compliance with global regulations.
Provide expert guidance to project stakeholders, ensuring timely and high-quality service delivery.
Develop regulatory strategies and tools, staying current with industry best practices and regulatory changes.
Alimentiv provides global regulatory affairs support services for clinical research. The company emphasizes high-quality service delivery, compliance with industry standards, and a collaborative culture.
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.
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.
Provide study oversight as primary liaison between CRAs, internal staff, site staff, client personnel, and external vendors.
Ensure clinical monitoring activities comply with SOPs, regulations, GCP, KPIs, and study-specific requirements.
Develop and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996, supporting research behind innovative treatments in pharmaceutical, biotech, and medical device industries. They foster a collaborative community where team members feel valued, supported, and empowered to make a meaningful impact on global health.
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.
Responsible for submission planning and management of IND-related activities, including annual reports, DSURs, and CTA activities.
Manages the compilation, QC, and submission of INDs, BLAs, and amendments, and prepares routine regulatory documents.
Represents Regulatory Affairs on cross-functional teams, providing expertise and managing submission trackers.
Iovance Biotherapeutics is a biotechnology company pioneering tumor infiltrating lymphocyte (TIL) therapy for cancer. It is a small, fast-paced company with a collaborative and innovative culture.
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.
Lead site activation strategies and oversee start-up activities across clinical studies.
Manage critical path plans and mitigate risks to ensure timelines are met.
Collaborate with cross-functional teams and clients to improve activation processes.
Our partner is a clinical research organization that supports the delivery of clinical trials. They are a global company with a collaborative culture focused on innovation and operational excellence.
Own end-to-end planning and execution of regulated clinical trials from study start-up through close-out.
Lead sponsor-side CRO and vendor management across the full study lifecycle.
Translate study requirements into operational plans and drive study-level strategic decision-making.
Oura empowers people to own their inner potential with award-winning products that provide insights into readiness, activity, and sleep quality. As a quickly growing company, we focus on helping people live healthier and happier lives, ensuring our team members have what they need to do their best work.
Independently conduct and document onsite and remote monitoring visits, ensuring protocol and regulatory compliance.
Serve as primary liaison between sponsor and investigative sites, managing data queries and site communications.
Mentor junior CRAs and participate in audits, inspections, and process improvement initiatives.
Alimentiv is a clinical research organization that provides clinical trial monitoring and site management services. The company fosters a dynamic, results-driven, and high-accountability environment with a focus on quality and compliance.
Lead diverse CRO teams through Inspection Readiness preparation for a global oncology protocol. - Manage document retrieval in pTMF, ensuring all documents are present and correctly filed. - Coordinate with CROs to complete and update a ~500-item Inspection Readiness checklist.
Artech is an IT staffing company that provides technical expertise to fill gaps in clients' skill-set availability. As the 10th largest IT staffing company in the US, it offers flexible project planning and execution solutions.
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.