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.
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.
Perform independent, accurate, and timely management of submissions/transactions/inquiries.
Provide advanced regulations resource for research oversight committees.
Work with leadership to identify, develop, and implement continuous training.
Oregon Health & Science University is committed to innovation in healthcare, education and research. They value a diverse and culturally competent workforce and are an equal opportunity and affrimative action employer.
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.
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.
Provide administrative and programmatic support for a VA Research Office
Process research proposals involving the use of animal subjects and the use of hazardous biological or chemicals in medical research
Support the Research Office to conduct audits of regulatory documents
Aptive Resources partners with federal agencies to achieve their missions through improved performance, streamlined operations and enhanced service delivery. They have 300+ employees nationwide and they apply technology, creativity and human-centered services to optimize mission delivery.
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.
Oversees legal aspects of research administration and contracting.
Reviews sponsored awards and clinical trial agreements.
Monitors grant and research policies and practices.
Dartmouth Health is New Hampshire’s largest academic health system, serving patients across northern New England with over 1,800 providers. They are committed to creating a welcoming and inclusive environment, honoring all within their organization and communities.
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.
Supports a team of Pre-Award Specialists and monitors workload.
Manages pre-award activities for grants and contracts within a RAS unit.
Ensures proposals meet agency and university guidelines and deadlines.
Emory University is a leading research university that fosters excellence and attracts 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.
Work closely with the Principal Investigator to oversee the execution of study protocols and ensure site compliance with Good Clinical Practice.
Be available to see subjects virtually or in-person, answer their questions, and resolve medical issues during the study visit.
Perform trial procedures as per delegation, including prescreening candidates, obtaining informed consent, and administering questionnaires.
Care Access is dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With hundreds of research locations, mobile clinics, and clinicians across the globe, they bring world-class research and health services directly to communities that often face barriers to care.
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.
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.
Review, draft, negotiate, and track legal agreements.
Work closely with the Clinical Operations study team.
Ensure deliverables align with defined study timelines.
Precision Medicine Group is a company that works in the pharmaceutical and healthcare industries. They are an equal opportunity employer that values diversity and inclusion.
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.