Independently oversees all aspects of study site management to ensure patient safety is protected.
Independently conducts all forms of site visits, including pre-study/qualification, initiation, routine monitoring, and close-out visits.
Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision's high quality and professional image.
Monitor and own the progress of clinical studies at investigative sites.
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.).
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. They have a strong focus on Oncology and Rare Disease and passionate about cultivating their culture with high CRA retention rates.
Support and observe clinical site monitoring services inhouse.
Provide monitoring and site management activities for full-service studies.
Conduct remote data review, support data query and closure activities.
Alimentiv is a global contract research organization (CRO) providing clinical trials and research services. While the employee count is not provided, they appear to foster a collaborative environment.
Oversight of site level tasks associated with efficient site activation.
Support the CRA team in preparing for site initiation visits (SIVs).
Perform initial contract and budget negotiations with the sites, as well as amended where applicable
Fortrea helps to turn the impossible into I'm possible. They deliver exceptional service to their patients, fueled by a shared commitment to teamwork and excellence.
Responsible for operational oversight of the site, site health and monitoring activities.
Support sites in understanding study expectations, timelines, and required deliverables.
Build and maintain strong, trusted relationships with investigators and site staff.
CSL Behring is a global biotherapeutics leader committed to saving lives. They focus on serving patients’ needs by using the latest technologies to discover, develop, and deliver innovative therapies. CSL's parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
Responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities.
Serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, Braveheart Bio represents an outstanding opportunity for ambitious, mission-driven professionals to make a tangible impact in a rapidly evolving therapeutic area.
Oversee and manage regional operational activities of global pivotal trials.
Develop and oversee procedures for troubleshooting and problem solving.
Maintain effective communication with vendors and internal departments.
Prilenia is a private biopharmaceutical company focused on developing transformative medicines for neurodegenerative diseases. With a highly committed and talented global team, they are developing pridopidine, an investigational neuroprotective therapy for ALS and Huntington’s disease.
Ensure the development and implementation of action plans.
Lead regional/therapeutic area project resourcing.
Develop, mentor, manage and coach GCM Managers.
Precision for Medicine is a global precision medicine clinical research services organization. They improve the clinical research and development process for new therapeutics by integrating clinical operations excellence, laboratory expertise, and advanced data sciences.
Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits.
Oversee the execution of Site Activation, site activation strategy, adhering to project timelines.
Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent.
Care Access is dedicated to making the future of health better for all by bringing world-class research and health services directly to communities. With hundreds of research locations, mobile clinics, and clinicians across the globe, they focus on ensuring every person has the opportunity to understand their health and access the care they need.
Performs on-site or remote monitoring visit activities.
Identifies investigators and verifies qualifications.
Trains investigational site staff as necessary.
Ergomed is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia. Our company allows for employee visibility, creative contribution and realistic career development.
Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance.
Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions.
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.
Provide strategic and administrative leadership for clinical research business and operational activities.
Ensure studies are conducted in accordance with regulatory requirements and sponsor expectations.
Drive operational performance, program growth, and team development across the clinical research enterprise.
Florida Cancer Specialists & Research Institute (FCS) has built a national reputation for excellence since 1984. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations, they utilize innovative clinical research, cutting-edge technologies, and advanced treatments.
Processes ICSRs according to SOPs and project-specific safety plans.
Enters data into Argus Safety Database and codes events, medical history, and meds.
Generates timely expedited regulatory reports and ensures safety report distribution.
Precision Medicine Group is expanding its capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru. They are an Equal Opportunity Employer that values diversity and inclusivity.
Facilitate the review and negotiation of clinical trial agreements (CTAs) and investigator grants between PSI Legal, the project team, and the study site.
Customize and prepare contractually binding site-specific documents in cooperation with PSI Legal.
PSI is a leading Contract Research Organization with 30 years in the industry. They offer a perfect balance between stability and innovation to both clients and employees, focusing on delivering quality and on-time services across a variety of therapeutic indications.
Manage site start up through activation readiness strategy and oversight of site start up delivery.
Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations and Contract Execution.
Collaborate and communicate with stakeholders to secure input for milestone planning and alignment of operational goals.
Precision for Medicine is a Clinical Research Organization with an integrated offering that enables precision medicine by combining clinical trial designs, experts, biomarker and data analytics solutions. They focus on rare diseases and oncology, in addition to other therapeutic areas.