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.
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.
Considered as the primary point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
Conducts site evaluation, site training, routine, and site closure monitoring activities under supervision, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs).
Customize site engagement strategy for assigned study (ies) under supervision. Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people's lives across several key therapeutic areas. For more information about AbbVie, please visit them at www.abbvie.com.
Lead and manage the day-to-day operational execution of assigned cell therapy trials.
Develop and manage study timelines, budgets, forecasts, and related operational metrics.
Partner with external vendors / CROs / service providers to ensure high quality and timely deliverables.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease and are guided by their core values.
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.
Precision Medicine Group is expanding its capabilities across Latin America. They are an Equal Opportunity Employer, with employment decisions made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
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.
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.
Independently coordinates assigned study activities in accordance with study protocols, SOPs, and applicable regulatory requirements.
Screens potential research participants for eligibility, documents inclusion/exclusion determinations, and escalates complex eligibility questions as needed.
Manages scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities with minimal supervision.
Synapticure provides instant access to expert neurologists, cutting-edge treatments and trials, and wraparound care coordination and behavioral health support in all 50 states through a virtual care platform. Partnering with providers and health plans, including CMS' new GUIDE dementia care model, Synapticure is dedicated to transforming the lives of millions of individuals and their families living with neurodegenerative diseases like Alzheimer’s, Parkinson’s, and ALS.
Prepare, compile, and submit regulatory documents to IRBs/ECs
Support migration from Complion to Florence eRegulatory
Maintain CVs, licenses, and GCP documentation
UniTriTeam is a global organization supporting 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.
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.
Assist Clinical Project Manager in the development and management of company-sponsored global clinical trials.
Provide support in site recruitment, site initiation, site payments and site close-out.
Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
ImmunityBio, Inc. is a commercial-stage biotechnology company that develops cell and immunotherapy products that are designed to help strengthen each patient’s natural immune system. The company is publicly traded with headquarters in Southern California, offering a collaborative environment with professional development opportunities.
Assist in contacting investigator sites to provide study specific information.
Ensure receipt, completeness and accuracy of clinical and administrative documents.
Coordinate distribution and shipment of study-related materials.
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 ability of the human immune system to recognize and attack diverse cancer cells in each patient.
Serve as leader of the local study team on assigned studies.
Manage and maintain accurate country level plans including timelines and budgets.
Implement startup and site activation plans at various levels.
Jobgether uses an AI-powered matching process to ensure applications are reviewed quickly, objectively, and fairly. They identify top-fitting candidates and shares this shortlist directly with the hiring company.