Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees.
Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
Maintain study regulatory binders and files and perform internal audit and quality assurance checks on regulatory documents.
The Regulatory Document Coordinator will have primary responsibility for document management activities supporting Regulatory Affairs. Key responsibilities include word formatting, PDF publishing, eCTD output review, submission archival, and document workflow management. This position will play an integral role in the execution of the Regulatory strategy world-wide, with multiple avenues for continued development.
Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.
Monitor and own the progress of clinical studies at investigative sites.
Coordinate all necessary activities required to set up and monitor a study.
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve the speed, cost and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease and boast extremely high CRA retention rates compared to industry averages.
Monitor clinical studies of investigational and approved products.
Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
Review data queries and listings, and work with the study centers to resolve data discrepancies.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They believe great work happens when team members feel valued, supported, and empowered, and they are committed to making a meaningful impact on global health.
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees
Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.
Assist with daily site activities, acting as the primary point of contact for the site.
Assist with training and mentoring research staff, upholding professional development goals.
Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.
Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
ICON plc is a world-leading healthcare intelligence and clinical research organization. ICON fosters an inclusive environment driving innovation and excellence.
Maintain full ownership and accountability for initiating phone contact to potential study participants.
Conduct phone-based pre-screening interviews for potential study participants to determine pre-qualification status and eligibility for onsite screening visits.
Input and record patient information and call notes into CTMS database and other portals and systems in compliance with standardized patient enrollment processes and procedures.
M3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical organizations.
Manages central laboratory and specialty vendors across clinical trials.
Provides support for sample related matters to clinical study teams.
Assists with vendor selection and oversight.
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind.
Document and communicate audit findings to management and recommend corrective actions to improve compliance. Provide staff education on privacy standards, compliance policies, and regulatory requirements. Review, investigate, and respond to facility inspections and/or deficiencies issued by regulatory agencies.
SimonMed Imaging is the fastest growing outpatient radiology practice in the Nation and is committed to excellence and improving patient care.
Oversight for traveling clinical staff supporting decentralized operations at events and sites.
Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations.
Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff).
Care Access aims to improve the future of health for everyone. With numerous research locations and clinicians globally, they deliver research and health services to communities facing barriers to care.
The Medical Director oversees clinical trials, data collection, and protocol implementation. Manages program development, working cross-functionally with various disciplines. Supports data analysis and contributes to the preparation of abstracts, presentations, and manuscripts.
Iovance is committed to cultivating and offering a diverse and inclusive work environment as an equal-opportunity employer.
Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.
GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.
Revise, expand, and optimize onboarding materials and workflows to create a standardized, role-specific, and site-relevant onboarding program.
Deliver hands-on, in-person onboarding and provide ongoing virtual support during the initial integration period and beyond, ensuring continuous guidance and reinforcement of learning.
Contribute to developing, reviewing and maintaining documentation, training templates, study-specific training, and platform-specific user guides tailored to Care Access tools
Care Access is working to make the future of health better for all. 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.
Performs cancer registry duties related to completion of abstracts for benign and malignant processes for the cancer database. Complies with the established standards of Commission on Cancer, Georgia Cancer Registry, and the Piedmont Cancer Committee. This is a remote position.
Join Piedmont to move your career in the right direction and be recognized for your contributions to exceptional patient outcomes.
Monitor and own the progress of clinical studies at investigative sites.
Coordinate activities to set up and monitor a study.
Train and mentor junior staff members.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the success rate of therapies for patients. They cultivate their culture and have high CRA retention rates compared to industry averages.