Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting for over 35 trials per year.
Serve as the internal project manager for assigned oncology disease groups, providing timely updates on submission status and regulatory guidance on study development.
Act as the liaison between sponsors, investigators, Winship, Emory IRBs, external IRBs, and internal departments, ensuring all facets of each protocol are compliant.
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.
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients globally. They look for mission-driven candidates who want to advance the fight against cancer and make a difference in patients' lives.
Conduct timely reviews of clinical trials relying on external IRBs or where Cooper serves as the reviewing IRB.
Ensure research upholds ethical standards, complies with SOPs, and supports clinical trial start-up.
Execute reliance agreements with support from the HRPP Director and Legal, when applicable.
Cooper University Health Care is committed to providing extraordinary health care. They are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols.
Support site initiation, management, and close-out activities.
Ensure trial conduct complies with protocol and regulatory requirements.
Participate in data review and support site readiness.
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 by staying true to their values and innovating boldly.
Coordinate day-to-day clinical trial operations remotely, ensuring compliance with study protocols and regulatory guidelines.
Support and facilitate remote patient visits, including scheduling, documentation, and follow-up.
Maintain accurate and timely data entry in EDC and CTMS systems and manage query resolution.
UniTriTeam is a global leader providing operational, administrative, and technology support to clinical research sites. They take pride in their mission to help advance medicine and make a real impact in healthcare, fostering a collaborative and supportive work 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. Founded in 2012, they have 300+ employees nationwide and specialize in applying technology, creativity and human-centered services.
Supports the development and execution of global regulatory strategy.
Maintains relationships with relevant regulatory agencies.
Identifies risks and interpret and communicate relevant issues to project team members and senior management.
Iovance Biotherapeutics aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. It is committed to continuous innovation in cell therapy, with a diverse and inclusive work environment.
Assist investment advisers and other financial services firm customers with regulatory obligations.
Process applications for new representatives of investment adviser and broker-dealer firms, including Form U4.
Coordinate with state and SEC regulators to secure registration for customer firms.
Comply is a leading provider of compliance SaaS and consulting services for the global financial services sector. They empower Chief Compliance Officers and their teams to proactively manage regulatory obligations, mitigate risk, and scale with efficiency and confidence, serving thousands of global financial services clients.
Manages the financial, regulatory, patient management, and human resources functions associated with conducting clinical trials.
Supervises a staff of 2 - 5 employees; trains new clinical trials staff; tracks enrollment, sponsor payments, and salary.
Provides leadership in business development and assists residents in preparing research projects by facilitating IRB submissions and protocol writing.
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.
Serve as the clinical lead for one or more clinical programs, with responsibility for clinical trial design, execution oversight, and delivery of key milestones.
Serve as medical monitor for assigned studies, including review of eligibility, protocol deviations, safety signals, SAEs/AEs, and benefit-risk assessments.
Contribute to global regulatory strategy and interactions with health authorities (FDA, EMA, PMDA, etc.).
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. They are a fully remote company headquartered in Radnor, Pennsylvania, with a culture that emphasizes collaboration and high-quality execution.
Responsible for executing clinical studies in compliance with quality standards.
Supports the Study Project Manager in leading the cross functional study team.
Supports the development of the clinical study blueprint/protocol and associated systems and documents.
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 including immunology, oncology and neuroscience.
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.
Provide administrative and programmatic support for research and program offices.
Support various research committees and initiatives, which may include the Subcommittee on Research Safety (SRS), the Institutional Animal Care and Use Committee (IACUC), and the Research and Development (R&D) Committee.
Process research proposals involving the use of animal subjects and/or hazardous biological or chemical materials in medical research, including receipt, logging, routing, tracking, inquiry, evaluation, review, action and response.
Aptive Resources partners with federal agencies to achieve their missions through improved performance, streamlined operations and enhanced service delivery. It was founded in 2012 and has 300+ employees nationwide, specializing in technology, creativity and human-centered services.
Maintain a working knowledge of Protocol Coordinator responsibilities and work instructions.
Provide quality control reviews on protocols, informed consent documents (ICDs), and supplemental documents across Leagues, as assigned.
Serve as the subject matter expert in the creation of Informed Consent Forms and Therapy Delivery Maps consistent with the organization’s standards.
COG Research Foundation, LLC is the federal grantee organization for the Children's Oncology Group (COG). The COG unites over 12,000 experts in childhood cancer at more than 220 leading children’s hospitals, universities, and cancer centers across the United States, Canada, Australia, New Zealand, and Saudi Arabia.