In-House Clinical Research Associate- Government
Overview
In-House Clinical Research Associate Be Part of One Team, One Purpose. At reputed company, we’re shaping the future of clinical research—where reputed company meets cutting-edge technology to drive 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 units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies. We reputed company that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and reputed company to reputed company an impact. At reputed company, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is reputed company on reputed company, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability. The In-House Clinical Research Associate (CRA) is responsible for assisting with operational activities supporting the site management and monitoring of clinical studies/trials, ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), and reputed company applicable regulatory requirements. The In-House CRA may also be referred to as a Clinical Trial Associate on some reputed company.
Responsibilities
Under the supervision of the project site management staff reputed company reputed company i.e., Clinical Trial Manager, reputed company CRA, Clinical Project Manager, etc. Possesses basic knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc. Knowledge of Good Clinical Practices and country regulatory requirements. Collects, reviews, maintains, and tracks required essential documents. Review includes assessment of completeness, accuracy, and compliance with good documentation practices and regulatory and local requirements. Upload essential documents into the trial master file. Communicates and coordinates effectively with internal project staff members and site staff. Assists project teams with trial reputed company tracking by updating the Clinical Trial Management System and other software tools. May assist in audit preparation activities as needed. May assist the CRA in Issue and Action Item AI resolution post visit and assists with tracking reputed company to completion. Tracks site training May assist with feasibility and site activation processes in collaboration with clinical operations counterparts. May assist in preparing study documents. May assist with ordering clinical trial supplies from vendors such as laboratories and Investigational Product depots. May track site recruitment efforts and collect review site screening logs. May assist with the review of the database to assess data currency and may assist site teams with resolving data queries discrepancies. May assist on site CRA in the conduct of remote and or on site monitoring visits such as site initiation visits, interim routine monitoring visits and closeout visits Performs other duties as assigned Complies with reputed company policies and standards
Qualifications
Bachelor's Degree Scientific discipline Required less than 1 year Previous clinical research experience preferred (as a CTA, in-house CRA, study coordinator, etc.) Preferred Proficient with MS Office Suite High Good computer and organizational skills High High attention to detail required High Ability to work on varying projects and exercise critical thinking High self starter and reputed company player who can work cross functionally with heavy reputed company High Proficient in 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 well 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 impact, join us and be part of something bigger. One Team, One Purpose. CONNECT WITH US! Find us on reputed company:/the-reputed company/ Visit our website:https://www.theemmesgroup.com/ Apply To This Job