Job Summary:
Subject matter expert and leader of a clinical trial team to conduct and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and Velocity’s SOPs.
Duties/Responsibilities:
• Serve as leader of a study team to execute clinical trials
• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
• Create training strategies and mitigation plans
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs
• Implement and coordinate assigned clinical trials including start up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
• Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members
• Develop communication and escalation strategies within teams to that ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
• Ensure staff are delegated and trained appropriately and documented
• Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
• Evaluate potential subjects for participation in clinical trials including phone and in person pre-screens.
• Create and execute recruitment strategies in conjunction with patient recruitment staff
• Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.
• Incorporate understanding of how decisions affect the bottom-line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.
• Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
• Develop Quality Control strategies for team member projects
• Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
• Promote respect for cultural diversity and conventions with all individuals.
• Understand the disease process or condition under study
• Other duties as assigned
Required Skills/Abilities:
• Advanced knowledge of medical terminology
• Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Proficient ability to work in a fast-paced environment
• Advanced verbal, written, and organizational skills
• Advanced interpersonal and communication skills
• Advanced ability to work as a team player
• Advanced ability to read, write, and speak English
• Demonstrated ability to multi-task
• Advanced ability to follow written guidelines
• Demonstrated ability to work independently, plan and prioritize multiple deliverables and objectives
• Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
• Must be detail oriented
• Proficient problem solving and strategic decision-making ability.
• Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
• Proficient leader, mentor and team builder
Education and Experience:
• Bachelor’s degree and 4 years as a Clinical Research Coordinator or
• Associate’s degree and 6 years as a Clinical Research Coordinator or
• High School Graduate and/or technical degree and 8years as a Clinical Research Coordinator
Required Licenses/Certifications:
• Phlebotomy qualification
• Intravenous/Intramuscular dose administration and preparation if applicable and required by state law
• Certified Clinical Research Coordinator through ACRP within one year of being in the role