Clinical Research Coordinator II

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high-quality data, and fully integrated research sites. We align our values and behaviors to give employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high-quality data from as many patients as possible, as quickly as possible while providing exemplary patient care.

About the role

The Clinical Research Coordinator II conducts and manages multiple clinical trials from start-up through study close-out in accordance with the study protocol, Good Clinical Practice (GCP), and Velocity’s Standard Operating Procedures (SOPs).

Responsibilities

• 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 document review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner, resolving queries, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, and 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.
• 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.
• Verify and escalate patient safety concerns by ensuring 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.
• Create and execute recruitment strategies defined by the Clinical Research Team.
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Understand the product development life cycle and significance of protocol design including critical data points.
• Understand the disease process or condition under study.
• Collaborate with the Clinical Research Team to develop a Quality Control strategy for reviewing one’s work on an ongoing basis and in preparation for monitor visits.
• Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope.
• Other duties as assigned.

Qualifications

• Bachelor’s degree and 2 years of relevant experience in the life science industry, OR
• Associate’s degree with 4 years of relevant experience in the life science industry, OR
• High School Graduate and/or technical degree with a minimum of 6 years of relevant experience in the life science industry.
• 1 year of Clinical Research Coordinator experience.

Skills

• Demonstrated knowledge of medical terminology.
• Proficient in the use of computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Proficient ability to work in a fast-paced environment.
• Proficient verbal, written, and organizational skills.
• Proficient interpersonal and communication skills.
• Proficient ability to work as a team player.
• Proficient ability to read, write, and speak English.
• Proficient ability to multi-task.
• Proficient ability to follow written guidelines.
• Proficient ability to work independently, plan, and prioritize with minimal guidance.
• Proficient ability to be flexible/adapt as daily schedule may change rapidly.
• Must be detail-oriented.
• Demonstrated problem-solving and strategic decision-making ability.
• Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued, and/or praised.
• Demonstrated leadership ability.

Physical Requirements

• 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.

Benefits

• Medical, dental, and vision insurance.
• Paid time off and company holidays.
• 401(k) retirement plan with company-match.
• Annual incentive program.