Insperity

Uniquely focused on community-based Hematology & Oncology research sites, we provide real-world experience, data, and outcomes that lead to improved clinical utility of cancer therapies, improving the lives of cancer patients.. Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICF Guidelines regarding drug development phases, clinical research, and data management methods.. Lead the study start-up process, including, but not limited to, the Trial Kick-off meeting, the set-up of the trial master file (TMF), the set-up of the electronic data capturing (EDC) system, site selection, and the finalization of site Clinical Trial Agreements and budgets.. Maintain the TMF to date, set up, and maintain the investigator site file (ISF) for all participating sites.. Prepare study regulatory documents, FDA, and IRB submissions such as yearly reports/renewals, SAEs, etc.

clinical project manager

Description & Requirements Clinical Project ManagerOnsite in West Hollywood, CAONCOtherapeutics is a full-service Contract Research Organization (CRO) with a unique focus in the therapeutic area of oncology. We are a strategic CRO running multiple clinical trials in community oncology sites throughout the United States (US). We provide the necessary support to major biopharmaceutical companies throughout the US to successfully run, enroll, and complete clinical trials. Uniquely focused on community-based Hematology & Oncology research sites, we provide real-world experience, data, and outcomes that lead to improved clinical utility of cancer therapies, improving the lives of cancer patients.We hire exceptional people. We want individuals who thrive on being challenged and are passionate about building a great company and growing with us. If you want your next step to be the right one, and you've worked hard to get where you are today, then we have the perfect opportunity for you.As the Clinical Project Manager, you will ensure project timelines and goals are met on time and within budget while following Good Clinical Practices (GCP), ICH, FDA, and best practices. This includes utilizing expert working knowledge to anticipate project roadblocks and solve problems efficiently and effectively. You will be the primary liaison between Oncotherapeutics and its clients (Sponsors and Sites), ensuring questions are answered and issues resolved. You must demonstrate the ability to manage multiple projects with different sponsors and timeline demands.To succeed, you should have:Bachelor’s degree in a scientific discipline2+ years' experience in clinical trial project management Therapeutic experience in oncology.Ability to work independently and establish and maintain effective working relationships with co-workers, supervisors, and other staff. Excellent interpersonal abilities are required.Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICF Guidelines regarding drug development phases, clinical research, and data management methods.Ability to solve problems. Must have effective time management and organizational skills.Read, write, and speak in fluent English. Excellent verbal and written communication skills.Willing to wear many hats in a growing company. Ability to work onsite in the West Hollywood, CA office.Your responsibilities as the Clinical Project Manager will include:Manage several multi-site clinical trials throughout the project's lifetime. Lead the study start-up process, including, but not limited to, the Trial Kick-off meeting, the set-up of the trial master file (TMF), the set-up of the electronic data capturing (EDC) system, site selection, and the finalization of site Clinical Trial Agreements and budgets.Develop project plans such as data management plans (DMPs), case report forms, data management plans, source document worksheets, central laboratory specifications, etc.Maintain the TMF to date, set up, and maintain the investigator site file (ISF) for all participating sites.Manage clinical research associates (CRAs), review and approve site trip reports; Oversee tracking, follow-up, and resolution of site issues. Assist in source data verification (SDV) as needed.Conduct site-initiating visits (SIV) and guide protocol and proper data collection.Organize and prioritize work according to study timelines and proactively address potential problems; Create tracking tools for weekly internal meetings and monthly reports to clients.Create effective and professional relationships with sites, vendors, and clients to ensure project goals are met. Act as liaison between Oncotherapeutics, sites, and sponsors.Ensure adherence to GCP, ICH, and FDA regulations and guidelines and international regulations.Prepare study regulatory documents, FDA, and IRB submissions such as yearly reports/renewals, SAEs, etc.; Manage submissions and distribution of documents to sites of protocols amendments, informed consent forms, investigator documentation, safety reports, and recruitment materials.Assist the Medical Writer with creating trial protocols, schedule of procedures, and informed consent, as needed.Provide efficient updates on the trial progress to the Director of Clinical Operation and CEO. Ensure potential risks are escalated to the appropriate team.Best-in-Class Benefits and Perks:We value their employees’ time and efforts. Their competitive compensation of $80K-$100K annually, depending on experience and extensive benefits package, enhances their commitment to your success. Our client’s benefits package includes: Comprehensive health coverage: Medical, dental, and vision insuranceRetirement planning: 401(k) plan with employer matchingFinancial security: Life and disability insuranceFlexible financial options: Flexible spending and health savings accountsWork-life balance: Generous paid time off and holidaysSupportive resources: Employee assistance programPlus, we maintain the best environment for their employees, where people can learn and grow with the company. They strive to provide a collaborative environment where everyone feels encouraged to contribute to their processes, decisions, planning, and culture.We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. We will consider qualified applicants with criminal histories for employment.

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