Cardiac Clinical Trials Specialist

Clinical Research Coordinator At Virginia Heart, we are looking for a professional Clinical Research Coordinator who will plan, direct, evaluate and analyze clinical research trials related to cardiac drug and device trials. Maintaining GCP/ICH guidelines and FDA regulations is always required. Benefits Affordable Medical, Dental and Vision plans 401(k) Retirement Plan Paid Short-Term Disability Employee Assistance Program for Mental and Physical well-being Three Weeks of Paid Vacation upon eligibility One week of Paid Sick Leave Annual Merit-Based increases Employee Discount Programs Quarterly Employee Appreciation Events to include therapy dogs, raffles, and other fun events. Roles and Responsibilities Monitors study activities to ensure compliance with protocols and with relevant federal, state regulatory and institutional policies. Ensure that all regulatory files are complete, accurate, and up to date. Coordinate study start-up activities, including IRB submission, site initiation visits, and pre-study visits. Serves as the primary point of contact for sponsors. 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 potential patients' eligibility through methods like screening interviews, reviewing 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 revisions. Prepares 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. Conducting monitoring visits and resolves issues as needed in a timely manner. Mentor and train junior research staff and new team members on study protocol, procedures and regulatory compliance. 10% Travel Required Skill Requirements and Qualifications Biology or Health Science degree, preferred Fluency in Spanish preferred At least three years of experience in clinical research coordination, preferably cardiology Clinical experience preferred Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred Strong organizational and analytical skills required In depth knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB requirements Proficiency and clinical trial management systems and electronic data capture platforms Flexibility with working hours to accommodate study needs Detailed oriented, excellent written and verbal communication skills Excellent time management skills, team player with the ability to work independently EMR experience, (EPIC a plus) and Microsoft Excel, Word and Outlook #J-18808-Ljbffr Virginia Heart