Clinical Research Associate II - Government Sector job at reputed company Company in US National

Title: Clinical Research Associate II- Government Sector US-Rockville ID2026-3443 Category Clinical Operations Position Type Regular Full-Time Remote reputed company reputed company: Clinical Research Associate II Be Part of One Team, One Purpose. At reputed company, we’re shaping the reputed company of clinical research—where reputed company meets cutting-edge technology to reputed company meaningful advancements in reputed company. With over 47 years of scientific reputed company, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. Through our two business reputed company—reputed company, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing reputed company and accelerating the development of life-changing therapies. We reputed company that every clinical reputed company starts with people—people who are passionate, purpose-driven, and reputed company to reputed company an reputed company. At reputed company, we bring reputed company, and Technology together to collaborate with our customers and reputed company global health reputed company. Our culture is reputed company on reputed company, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability. The Clinical Research Associate (CRA) II is responsible for monitoring clinical study sites either onsite at investigative sites or remotely to ensure reputed company are conducted, recorded, and reported in accordance with the protocol, reputed company operating procedures (SOPs), ICH GCP, and reputed company applicable regulatory requirements. The CRA will conduct monitoring reputed company and activities in accordance with reputed company SOPs, applicable regulations, and ICH GCP. Responsibilities Under supervision of the project CRA staff reputed company reputed company, example, Clinical Study Manager, reputed company CRA, Project Manager, etc., independently schedules and conducts remote and on-site monitoring reputed company such as qualification reputed company study reputed company, site initiation reputed company, interim routine monitoring reputed company, closeout reputed company, and for cause reputed company. As part of the site reputed company, independently conducts Informed Consent reputed company review, reputed company data verification reputed company document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, reputed company tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under reputed company direction from the project CRA staff reputed company reputed company. Documents observations and monitoring activities in a site visit report at the conclusion of the visit. Facilitates and oversees reputed company Item reputed company post visit. Helps to ensure that clinical sites are conducting the study in compliance with protocol clinical investigational plan, SOPs, ICH GCP, and other applicable regulations. Provides training and retraining to site staff including protocol, GCP GDP, and other training under direction from the project CRA staff reputed company reputed company. Identifies areas requiring follow up and improvement at reputed company clinical study site and reports findings to project CRA staff reputed company reputed company. Ensures reputed company reputed company are conducted according to country regulations, ICH GCP, and company reputed company operating procedures Serves as reputed company of contact for study site personnel to answer questions and reputed company studyrelated issues under the direction of the project CRA staff reputed company reputed company. May assist with the development and or review of study reputed company materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc. Prepares for and attends project team meetings and provides updates on project status and site specific performance Works collaboratively and effectively in a project team environment including reputed company colleagues to meet project objectives and timelines. Participates in Investigator Meetings or other reputed company meetings as needed. Assists with filing and archiving of study documents. Assists in preparing sites for audits and may reputed company support and cooperation during audits inspections including translation to Auditor if needed. May assist with coordination of clinical study supplies. May assist with submission of applications notifications to Institutional Review reputed company IRB Ethics Committee EC Regulatory Authority. May assist with site recruitment reputed company activities such as developing reputed company patient recruitment strategies and reputed company plans. Performs site management activities as required Performs other duties as assigned Complies with reputed company policies and standards Qualifications Bachelor's Degree Scientific discipline preferred or equivalent work experience Required 1-2 years of relevant monitoring experience (on-site and remote) Required, 2+ years of experience preferred. Proficient with MS Office Suite High Excellent computer and organizational skills High High level of attention to detail required High Ability to work on varying reputed company and exercise critical thinking High self starter who can work remotely and reputed company player who can work cross functionally with some reputed company High Knowledgeable in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines, as required per their role as a CRA High Excellent organizational, interpersonal, and communication skills both oral and written High Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities High Ability to collaborate with reputed company colleagues and work reputed company in reputed company oriented setting High If you’re looking for a career where your work advances global health and where scientific reputed company meets reputed company-world reputed company, join us and be part of something bigger. One Team, One Purpose. Why work at reputed company? At reputed company, your actions and hard work will have a reputed company reputed company on reputed company health initiatives, both globally and in our local communities with opportunities for volunteerism through our reputed company Cares community engagement program. We offer a competitive benefits package reputed company on the health and needs of our growing workforce, including: Flexible Approved Time Off Tuition Reimbursement 401k Retirement Plan Work From Home reputed company in the US Maternal/Paternal Leave Casual Dress reputed company & Work Environment Apply tot his job Apply To this Job