Conduct on-site or remote monitoring visits to ensure site adequacy for clinical trials.
Train investigational site staff and support regulatory submissions as needed.
Mentor junior staff and perform co-monitoring visits to assess performance.
Ergomed Group provides clinical research, pharmacovigilance, and consulting services to biopharmaceutical companies, focusing on oncology and rare diseases. With a global team, they emphasize collaboration, kindness, and professional growth in a values-driven culture.
Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols and regulations.
Coordinate study setup activities, including investigator identification and regulatory submissions, while mentoring junior staff.
Interact directly with clients, manage payments, and participate in proposal activities, with travel up to 50-60%.
Precision for Medicine is a specialized CRO that combines agility with scientific expertise to support innovative clinical development programs. They foster a collaborative environment that values quality, accountability, and professional development, with a global team of experienced professionals.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Conduct and report all types of onsite monitoring visits, perform CRF review, source document verification, and query resolution.
Be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level.
Support regulatory team in preparing documents for study submissions and participate in feasibility research.
PSI is a leading Contract Research Organization with over 30 years of experience, offering a balance of stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.
Manage Investigator sites and conduct on-site and centralized monitoring visits to ensure subject safety and data integrity.
Collaborate with cross-functional teams and external partners to maintain quality study oversight from start-up through close-out.
Support development of study documents, maintain TMF, and ensure inspection readiness while embodying core company values.
MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. The company combines cutting-edge technologies like optogenetics and spatial transcriptomics to identify novel drug targets, with a culture of integrity, collaboration, bravery, and dedication.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.
Independently manages the study start up activities for multi-center, US and/or global based studies.
Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance.
Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. They are pioneering a transformational approach to treating cancer by harnessing the immune system, and are committed to continuous innovation in cell therapy.
Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
Independently manages significant aspects of clinical trials and research projects.
Trains and provides guidance to less experienced staff, and oversees data management.
Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.
Responsible for site activation readiness, submission preparation, and interaction with Competent Authorities and Ethics Committees.
Manage essential document collection, informed consent customization, and maintain project plans and trackers.
Partner with cross-functional teams and act as subject matter expert for country-specific regulatory knowledge.
We are a global life sciences company specializing in clinical trial regulatory and start-up services. We are expanding our capabilities across Latin America and seek experienced professionals to join our team.
Manage site activation and regulatory submissions for clinical trials in Spain.
Oversee contract and budget negotiations with sites to ensure timely approvals.
Collaborate with cross-functional teams to maintain project documentation and timelines.
Precision for Medicine is a global Clinical Research Organization specializing in precision medicine for rare diseases and oncology. The company is experiencing continued growth and values operational excellence and regulatory expertise.
Create eSource for new studies according to protocol specifications.
Distribute eSource to applicable sites and collaborate with local staff to ensure site-specific eSource requirements are implemented.
Serve as a subject matter expert for eSource creation and mentor clinical sites.
Headlands Research is a leading network of advanced clinical trial sites dedicated to enhancing clinical trial delivery within communities using cutting-edge technology and exceptional support services. Founded in 2018, the rapidly growing company currently operates 20+ sites across the US and Canada with a mission-driven culture focused on advancing medicine.
Build and manage a country-specific network of referring physicians across various therapeutic areas.
Plan and conduct regular visits to physicians to promote collaboration and document key discussions.
Collaborate with Clinical Operations, Regulatory, and Legal to ensure successful referral process implementation.
We are a global clinical research organization (CRO) founded in 1995, focused on bringing new medicines to patients. With 3,000 employees, we are dedicated, passionate, and driven, prioritizing care for our staff, clients, and partners.
Manage regulatory submissions and site activation for clinical trials in Spain, ensuring compliance and timelines.
Negotiate site contracts and budgets, and coordinate with Competent Authorities and Ethics Committees.
Maintain project trackers, oversee essential documents, and support translation activities for patient materials.
Precision for Medicine is a global Clinical Research Organization specializing in precision medicine, combining novel trial designs, biomarkers, and data analytics. They focus strongly on rare diseases and oncology, and their culture emphasizes innovation, collaboration, and regulatory excellence.
Establish and maintain relationships with investigators, sites, and key opinion leaders to support trial execution.
Gather site feedback and translate it into actionable improvements for study teams.
Contribute to protocol development, site selection, and business development activities.
This role is with a partner company that focuses on clinical research and trial execution. The company operates remotely and values collaboration, inclusion, and professional autonomy.
Manage clinical study vendors and ensure deliverables are on time, within budget, and compliant with FDA and ICH/GCP guidelines.
Support CRO collaboration, site start-up, study documentation, and risk mitigation with cross-functional teams.
Leverage AI tools and process improvements to enhance clinical operations productivity and quality.
This biotechnology company focuses on developing innovative oncology therapies. It offers a collaborative, multidisciplinary environment with opportunities to use AI-enabled tools and modern approaches to clinical operations.
Manage end-to-end clinical studies ensuring on-time and on-budget delivery with high quality standards.
Lead multifunctional study management teams and serve as primary point of contact for client study teams.
Oversee project planning, resource allocation, and financial management while ensuring regulatory compliance.
Science 37 is a clinical research organization focused on decentralized clinical trials. They value employee well-being and provide an equal opportunity workplace.
Prepare and maintain Trial Master Files for internal and external studies to meet sponsor specifications.
Communicate with sponsors, project managers, and study contacts to ensure compliance with protocols and regulatory requirements.
Manage multiple priorities and ensure file structure and indexing are accurate.
Celerion is a clinical research organization that uses translational medicine to accelerate drug development. The company values integrity, trust, teamwork, and respect, and is an equal opportunity employer.
Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.