Clinical Trial Associate in Actalent

ResponsibilitiesMaintain the Trial Master Files (TMF): Responsible for the on-going management of the TMF for assigned clinical trials. This is inclusive of receipt, review, QC, tracking and filing of all documents per the SOPs required within the conduct of assigned clinical trials.Ensure all TMF documents are up to date such as 1572’s CV’s and Investigator Medical Licenses to ensure audit readiness.Assist with the development and maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits and site payments.Work with Clinical Operations to assist in the oversight of CROs, as appropriate, to ensure the successful conduct of clinical trials, including attending and participating in Clinical Trial Working Groups as needed.Assist in reviewing monitoring visit reports to ensure proper conduct and oversight as needed.Review site-specific Informed Consent FormsTracks site feasibility questionnairesAssist in the planning of various meetings and events for the Clinical Operations TeamReconcile invoices to their corresponding contracts and budget, and assist with investigator site payments.Prepare and manages study communications including newsletters and study updatesRecords, prepare and distributes meeting minutes for assigned clinical trials or as designated by the VP of Clinical Operations. Work closely with Clinical Trial Managers to assist with preparation of all external and internal documentation for assigned trials to ensure it's completed in accordance with GCP regulatory requirements and consistent with the study protocol.Minimum Requirements:Two or more years’ experience as a clinical research coordinator Oncology experienceTMF experience preferred About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options. Show more Show less Должностной уровень Молодой специалист Тип занятости Полный рабочий день Должностные обязанности Научно-исследовательская деятельность, Аналитические исследования и Информационные технологии Отрасли Бизнес-консалтинг и услуги