Clinical Research Coordinator I

Summary

The Clinical Research Coordinator I conducts and manages clinical trials in accordance with the study protocol, GCP, and Velocity's SOPs.

Responsibilities

• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity's SOPs
• Coordinate, with 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, managing, and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing 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
• Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries
• 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
• Ensure staff are delegated and trained appropriately and documented
• 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

Education/Experience 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

Required Licenses/Certifications

• Phlebotomy if applicable and required by state law
• Intramuscular dose administration and preparation if applicable and required by state law

Required Skills

• 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 a telephone
• Limited walking required
• Limited to lifting up to 30 pounds

Pay

$52,000-62,000