Establishes and maintains a document management system for regulatory electronic files.
Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks.
Modifies and/or develops informed consent forms and updates and manages protocol, investigator drug brochure and consent form modifications or amendments in compliance with IRB policy and HIPAA.
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.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.
Assist in preparing regulatory submission documents in compliance with global regulatory requirements.
Manage the preparation and submission of preclearance and promotional material submissions to the U.S. FDA.
Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs.
Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
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.
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.
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.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
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.
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.
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.