Clinical Research Coordinator

Company: Actalent
Location: Leesburg
Posted on: March 11, 2023

Job Description:

Description:The Clinical Research Coordinator position requires planning, directing, evaluating, and analyzing clinical research trials related to cardiac studies. Must maintain GCP/ICH guidelines and FDA regulations.Monitors study activities to ensure compliance with protocols and with relevant, federal, state regulatory and institutional policies. Maintains required records of study activity including case report forms, drug dispensation records, or regulatory forms. Tracks enrollment status of patients and documents dropout information such as dropout causes and patient contact efforts.Assesses eligibility of potential patients through methods such as screening interviews, review of medical records, and discussions with physicians and assistant physician providers. Responsible for education and appropriate documentation of patient informed consent. Records adverse event and side effect data and confers with investigators regarding the reporting of events to oversight agencies. Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups. Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisionsPrepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.Participates in preparation and management of research budgets and monetary disbursements.Additional Skills & Qualifications:VA State Registered Nurse LicenseMinimum of 3 years prior clinical experience requiredMinimum of 3 years prior clinical research study coordination (preferably cardiology) experience requiredKnowledge of regulatory document collection and IRB interaction About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Leesburg , Clinical Research Coordinator, Healthcare , Leesburg, Virginia