Source Job

• Lead Risk-Based Quality Management (RBQM) activities to ensure clinical trial quality and alignment with study objectives.
• Oversee centralized monitoring, including developing Central Monitoring Plans, reviewing KRIs/QTLs, and maintaining dashboards.
• Collaborate with global teams and sponsors to identify risks, recommend mitigations, and support inspection readiness.

A global clinical research organization focused on advancing medical innovation and improving patient outcomes through high-quality clinical trials. The company fosters a collaborative, multidisciplinary remote environment with international teams and a strong emphasis on regulatory compliance and data-driven decision-making.

• Perform on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visits to ensure sites are adequate for study conduct.
• Verify investigator qualifications, resources, facilities, equipment, and staff for clinical study conduct.
• Train site staff, support regulatory/EC submissions, and mentor junior staff during co-monitoring visits.

Ergomed Group is a global clinical research organization helping biopharmaceutical companies develop and deliver therapies in oncology, rare disease and other complex areas. Its diverse teams across countries and time zones collaborate with kindness, curiosity and a shared sense of purpose.

• Partner with cross-functional teams and study sites to support clinical operations across all trial phases.
• Perform remote monitoring of clinical trials and serve as secondary contact for sites supporting CRAs.
• Ensure proper reporting and follow-up of SAEs, address non-compliance issues, and assist with audit/inspection readiness.

Premier Research is a global clinical research, product development, and consulting company helping biotech, specialty pharma, and MedTech innovators turn breakthroughs into new treatments. The company fosters a collaborative culture focused on agility, continuous learning, and making an impact.

• Manage advanced clinical site monitoring and ensure compliance with protocols and regulations.
• Oversee risk-based monitoring, source data verification, and site performance.
• Mentor junior CRAs and collaborate with cross-functional teams to support study execution.

Karius is a clinical metagenomics company using genomics and AI to improve infectious disease diagnosis. It is a venture-backed startup with a mission-driven culture focused on advancing diagnostic science.

• Monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP.
• Coordinate study setup and initiation activities, including investigator identification and regulatory submissions.
• Identify study risks and propose mitigation strategies while maintaining high quality and detail.

Precision for Medicine is a CRO integrating clinical trial execution with scientific expertise and data sciences, focusing on Oncology and Rare Disease. It offers a supportive, small-CRO culture with high CRA retention and emphasis on work-life balance.

• Lead a centralized team of Data Coordinators to ensure accurate, timely, and complete clinical research data.
• Manage workload, quality, and compliance for data activities across the Care Access site network.
• Partner with clinical operations, sponsors, and CROs to resolve data issues and improve processes.

Care Access brings clinical research and health services directly to communities through hundreds of research locations and mobile clinics. They are dedicated to making health care more accessible and put people at the heart of medical progress.

• Monitor and own study progress at sites, ensuring compliance with protocol, SOPs, ICH-GCP, and regulations.
• Coordinate setup: investigators, regulatory submissions, pre-study and initiation visits.
• Identify risks, propose mitigations, and become a protocol expert with a lower protocol load.

Precision for Medicine is a clinical research organization that combines novel clinical trial designs, advanced biomarker and data analytics, and specialized expertise in rare diseases and oncology. It is a smaller CRO with high CRA retention, a supportive culture, and a focus on giving employees influence and impact.

• Conduct and report all types of onsite monitoring visits, including CRF review and source document verification.
• Manage site communication and serve as the point of contact for in-house support services and vendors.
• Support regulatory document preparation and participate in feasibility research for clinical studies.

We are a global CRO founded in 1995, working on the frontline of medical science to bring new medicines to patients. We bring together over 3000 dedicated professionals in a culture that cares for staff, clients, partners, and quality.

• Serve as primary point of contact for testing sites ensuring protocol compliance and data quality.
• Drive operational execution of clinical studies from start-up to close-out.
• Collaborate with cross-functional teams to align on study execution and quality expectations.

Natera is a global leader in cell-free DNA testing dedicated to oncology, women's health, and organ health. The team consists of highly dedicated professionals from world-class institutions who care deeply for their work and each other.

• Train, mentor, and supervise junior Clinical Research Associates in their study-level responsibilities.
• Conduct site selection, initiation, routine monitoring, and closeout visits for clinical trials.
• Ensure regulatory compliance and data accuracy through CRF review and query resolution.

The partner company is a clinical research organization specializing in complex clinical studies. It fosters a people-focused culture with opportunities for professional growth and mentoring.