Develop and maintain successful working relationships with study sites, serving as the primary point of contact for clinical trial operations.
Conduct monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements, preparing high-quality reports.
Collaborate with cross-functional teams including Clinical Project Managers, Data Management, and Regulatory Affairs to ensure end-to-end study execution.
CVRx pioneers unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. The company values commitments to others and fosters a culture of teamwork, collaboration, and positivity in a purpose-driven startup environment.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
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.
Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.
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.
Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.
Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.
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.
Collaborate with project teams and clinical sites to support study startup, training, and device deployment.
Ensure compliance with GCP, ICH guidelines, and regulatory standards while monitoring project progress.
Address operational issues and provide feedback to improve devices and workflows.
Beacon Biosignals is transforming precision medicine for the brain by offering at-home EEG platforms for clinical development and diagnostics. The company fosters a remote-first culture with office hubs in Boston, New York, and Paris, emphasizing asynchronous work and collaboration.
Complete the CRA Training Program (12-14 weeks) to gain the skills needed as a primary CRA.
Conduct site visits (PSSV, SIV, IMV, COV) and manage site performance, data quality, and patient safety.
Build strong relationships with site personnel and ensure effective communication with the Clinical Study Team.
BeOne is a global oncology company discovering and developing innovative, affordable treatments for cancer patients worldwide. Our growing global team of more than 11,000 colleagues fosters a collaborative, patients-first culture.
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.
Coordinate day-to-day execution of clinical studies including site onboarding, documentation, and timeline tracking.
Support regulatory compliance through IRB submissions, amendments, and maintaining study documentation.
Collaborate cross-functionally with science, bioinformatics, and product teams to ensure study operations.
Tiny Health advances lifelong health through precision microbiome science using shotgun metagenomics and AI. Founded in 2020, it is a remote-first startup with a diverse international team focused on making the microbiome measurable and actionable.
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.
Independently conduct on-site and remote monitoring visits (SQVs, SIVs, IMVs, COVs) per protocols and regulations.
Manage site relationships, perform source data verification and review, and resolve data discrepancies.
Track monitoring findings, escalate risks, and maintain inspection-ready documentation.
Karius is a venture-backed life science company focused on clinical metagenomics, using genomics and AI to detect infectious diseases from microbial DNA in blood. The company is dedicated to advancing diagnostic science and improving patient care.
Responsible for executing one or more elements of clinical studies in compliance with quality standards and regulations.
Supports the Study Project Manager in leading cross-functional study teams and developing study protocols.
Manages vendor selection, oversight, and study-related training, and proactively resolves issues.
AbbVie is a biopharmaceutical company focused on discovering and delivering innovative medicines and solutions for serious health issues. It is a large global organization with a diverse workforce and a commitment to integrity and innovation.
Support clinical trial activities across patient engagement, study coordination, recruitment, regulatory support, data management, and operations.
Coordinate participant visits, recruitment, and regulatory documentation while maintaining accurate information in clinical research systems.
Foster communication between sponsors, CROs, investigators, and sites to ensure study compliance and milestone achievement.
This partner company supports fast-growing remote clinical research environments, helping keep clinical trials organized, compliant, and moving forward. They collaborate with research sites, sponsors, CROs, and healthcare organizations globally, offering multidisciplinary roles in a remote setting.
Act as the frontline connection between Care Access and potential study participants through phone, email, and mail.
Educate patients about clinical research and conduct remote pre-screening using checklists to assess eligibility.
Maintain meticulous records, schedule study visits, and collaborate with study teams and coordinators.
Care Access is a healthcare research company that brings clinical trials and health services directly to communities through hundreds of locations and mobile clinics. They are a global team with a culture focused on making health more accessible and putting people at the heart of medical progress.
Lead all clinical study operations, providing strategic planning and direction from inception through completion.
Serve as the primary contact with sponsors and oversee study budgets, timelines, and vendor management.
Mentor and motivate study team members while ensuring compliance with GCP, protocols, and regulatory requirements.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Our team of skilled professionals is committed to advancing clinical research with care, integrity, and excellence, fostering a collaborative and supportive culture.
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.
Serves as regulatory document specialist for clinical trial start-up, maintenance, and close-out.
Collects, reviews, and maintains essential documents in the electronic Trial Master File (eTMF).
Communicates with study teams and sites to ensure regulatory files remain complete and inspection-ready.
St. Jude Children’s Research Hospital is a leading research and treatment center focused on pediatric catastrophic diseases. It is a large institution with a collaborative culture and a strong emphasis on finding cures and saving children.
Coordinate and oversee all activities for site activations in accordance with contract, protocol, ICH-GCP, and regulatory requirements.
Act as primary point of contact for Sponsor and internal stakeholders during study start-up, developing strategy and managing regulatory deliverables.
Prepare, collect, review regulatory information for submissions and track essential documents to facilitate efficient site initiation and activation.
Ergomed is a specialist clinical research organization focused on rare disease and oncology indications. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance.