Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.
Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.
Accountable for leading assigned clinical research activities and partnering with stakeholders on study design.
Conducts on-site and remote site visits, including qualification, initiation, monitoring, and close-out.
Tracks study progress, manages budgets, and mentors junior clinical study managers.
Intuitive is a pioneer and market leader in robotic-assisted surgery, dedicated to minimally invasive care. With over 25 years of experience, the company fosters an inclusive and diverse team culture where employees are empowered to do their best work.
Provide operational oversight and support for multiple clinical research sites within the network.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Build and maintain strong working relationships with Sponsors, CROs, and external partners.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Supports all phases of clinical development and execution.
Ensures high quality data by being the study protocol expert and key site resource for questions.
Maintains and tracks clinical study data and supports investigator qualification selection.
SI-BONE is a medical device company focused on minimally invasive sacropelvic solutions. They aim to help patients with sacroiliac pelvic conditions and have provided over 90,000 procedures to date using their iFuse Implant System.
Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities.
Support Clinical Trial Managers in overseeing CRO deliverables, timelines, issue escalation, and overall study operational performance.
Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times.
Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, they've built a global team of over 100 employees headquartered in Boston, with a focus on advancing their lead asset. We encourage people from all backgrounds to apply and cultivate a culture where all voices are included.
Develops/maintains project timeline inclusive of startup through completion.
Drives development, approval, and distribution of study-related documents and study tools.
Manages distribution, collection and tracking of regulatory documentation.
Penumbra, Inc. is a global healthcare company focused on innovative therapies. They design, develop, manufacture, and markets novel products and has a broad portfolio that addresses challenging medical conditions.
We welcome professionals from a variety of backgrounds and experience levels within clinical research.
We look for those passionate about Clinical Operations, Site Enablement & Site Management, and Clinical Business Development Functions.
We also welcome professionals from Regulatory & Compliance, Feasibility & Patient Recruitment, and Patient Access & Healthcare Innovation.
Milestone One's mission is to bring clinical trials to a much broader range of sites and patients around the world. It is a fast-growing global startup operating in an international, multicultural environment that is always looking to connect with talented professionals who are excited to grow with us and contribute to its mission.
Lead and oversee clinical monitoring activities for Phase 1–3 global trials.
Establish CRO oversight, manage vendor performance, and ensure compliance with ICH-GCP.
Build scalable monitoring infrastructure, develop SOPs, and drive continuous improvement.
Oruka Therapeutics develops novel biologics for chronic skin diseases like plaque psoriasis. They are an emerging biotech company building a core team with a focus on establishing an engaged, inclusive, and positive culture.
Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in compliance with GCP, ICH, and SOPs.
Build and maintain strong relationships with investigator sites, providing training and guidance to ensure study quality.
Support IRB submissions, regulatory documentation, and trial master file quality across clinical programs.
CoMind develops non-invasive neuromonitoring technology for clinical brain monitoring. The company is a cutting-edge startup focused on improving diagnosis and treatment of brain disorders, with a culture that embraces AI in daily work.
Reviews patient data for Phase I-IV clinical research and non-interventional studies to ensure compliance with protocols and regulatory requirements.
Communicates and escalates serious issues to the project team and develops action plans as needed.
Maintains working knowledge of ICH/GCP guidelines and company SOPs, documenting activities per project requirements.
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We are a global company with over 29,000 employees, dedicated to developing our people and building an inclusive culture.
Manage and motivate a team of CRAs to achieve Precision for Medicine’s quality standards.
Support the career development of the organization’s Clinical Research Associate (CRA) workforce.
Strengthen the quality and productivity of operations within the group.
Precision for Medicine is a Clinical Research Organization with a uniquely integrated offering. They combine novel clinical trial designs, industry-leading operational and medical experts, and advanced biomarker and data analytics solutions.
Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.
Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.
Support operational delivery of clinical trial services including rater training, clinician network management, data management, and scale management.
Process clinician forms, document data, schedule training video conferences, and manage hardware shipment logistics.
Serve as point of contact for clinician/rater support and interact with site coordinators and CRAs for monitoring activities.
Cogstate advances brain health assessment with digital cognitive tools trusted by researchers and clinicians globally. With a global team of experts spanning psychology, data science, and operations, they have supported over 2,000 clinical trials in more than 150 countries, fostering a patient-first and collaborative culture.
Serves as the medical monitor for clinical trials and assists in resolving major issues that may affect their assigned studies.
Partners with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other members of the study team to conduct the clinical studies.
Provides expert opinion and review for creation of key study documents, including clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms.
Cullinan Therapeutics is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for cancer and autoimmune diseases. They have a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, and are advancing its mission to deliver new standards of care for patients.
Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Monitor and interpret CMS guidance for Medicare, Medicaid, and other healthcare programs.
Partner with internal teams to ensure compliance with regulations and contract obligations.
Maintain regulatory tracking documentation and support development of training materials.
HealthEdge provides healthcare software and services to payers and providers. It is a growing company with a focus on compliance and innovation, fostering a collaborative and remote-friendly culture.
Review, draft, and negotiate clinical trial agreements and budgets across European sites.
Serve as a subject matter expert and mentor to staff on contract management processes.
Coordinate with study teams and sponsors to ensure contract execution aligns with study timelines.
Precision for Medicine is a life sciences company that provides clinical research services. They are an established organization with a focus on supporting clinical trials and employ a global team with a culture of collaboration and professionalism.