Clinical Research Coordinator I

Responsibilities

• Detect and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity’s SOPs
• Coordinate, under supervision, 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
• Manage and report adverse events, serious adverse events, and deviations
• Implement new protocol amendments
• Provide all close-out reports
• Implement research and administrative strategies to successfully manage assigned protocols
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors
• Maintain confidentiality of patient protected health information, sponsor confidential information, and Velocity confidential information
• 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
• Create, collect, and submit 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
• Execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol
• 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

Qualifications

• Bachelor’s degree with 1 year of relevant experience in the life science industry OR Associate’s degree with 2 years of relevant experience in the life science industry OR High School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industry
• Phlebotomy if applicable and required by state law
• Intramuscular dose administration and preparation if applicable and required by state law
• Demonstrated knowledge of medical terminology
• Demonstrated ability in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone
• Demonstrated ability to work in a fast-paced environment
• Demonstrated verbal, written, and organizational skills
• Demonstrated interpersonal and communication skills
• Demonstrated ability to work as a team player
• Demonstrated ability to read, write, and speak English
• Demonstrated ability to multi-task
• Demonstrated ability to follow written guidelines
• Demonstrated ability to work independently, plan and prioritize with some guidance
• Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
• Must be detail oriented
• Demonstrated problem-solving and strategic decision-making ability
• Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued, and/or praised
• Required Physical Abilities: Sit or stand for long periods of time, travel locally and nationally, communicate in person and by telephone, limited walking required, limited to lifting up to 30 pounds