Overview:

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our 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 at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

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.

Role & 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 prescreens.
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

Education/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 8 years as a Clinical Research Coordinator

Required Licenses/Certifications:

Phlebotomy if applicable and required by state law
Intravenous/Intramuscular dose administration and preparation if applicable and required by state law
Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role

Required Skills:

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

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

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

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Cincinnati, Blue Ash jobs

Senior Clinical Research Coordinator