Senior Clinical Research Coordinator - Columbus

Overview:

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.

Responsibilities:

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,

• Create training strategies and mitigation plans
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines

• Implement and coordinate assigned clinical trials including start up, vendor management,

• Apply project management concepts to manage risk and improve quality in the conduct of a

• Develop, coordinate, and implement research and administrative strategies to successfully

• Communicate effectively and professionally with coworkers, leadership, study subjects,

• Ensure good documentation practices are applied by team members when collecting and

• Ensure confidentiality of patient protected health information, sponsor confidential information

• Develop communication and escalation strategies within teams to that ensure patient safety is

• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely

• Ensure staff are delegated and trained appropriately and documented
• Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs

• 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

• Incorporate understanding of how decisions affect the bottom-line including links between

• Incorporate understanding of product development lifecycle and significance of protocol

• Develop Quality Control strategies for team member projects
• Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG,

• Promote respect for cultural diversity and conventions with all individuals.
• Understand the disease process or condition under study
• Other duties as assigned

Qualifications:

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

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.
• Profcient 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 Abilites:

• 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

All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.