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. 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

• The Clinical Research Coordinator II conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and Velocity’s SOPs.

Role & Responsibilities

• Verify and escalate patient safety concerns by ensuring all adverse events, serious adverseevents, and adverse events of special interest are followed and reported in accordance withthe protocol and Velocity SOPs.
• Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
• Ensure staff are delegated and trained appropriately and documented
• Create and execute recruitment strategies defined by Clinical Research Team
• 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 timelymanner and all queries are resolved, managing and reporting adverse events, serious adverseevents, and deviations, implementing new protocol amendments, providing all close outreports.
• Collaborate with Clinical Research Team to develop Quality Control strategy for reviewingone’s work on an ongoing basis and in preparation for monitor visits.
• Maintain confidentiality of patient protected health information, sponsor confidentialinformation and Velocity confidential information
• Apply good documentation practices when collecting and correcting data, transferring data tosponsor/CRO data capture systems and resolving queries
• Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors.
• Other duties as assigned
• Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG,lab processing) within scope
• Apply project management concepts to manage risk and improve quality in the conduct of aclinical research study
• Understand key timelines, endpoints, required vendors, and patient population for eachassigned protocol.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timelymanner
• Create, collect and submit regulatory documents to Sponsors and IRBs as required perprotocol, GCP/ICH regulations and IRB requirements.
• Develop, coordinate, and implement research and administrative strategies to successfullymanage assigned protocols.
• Understand product development lifecycle and significance of protocol design includingcritical data points
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelinesand Velocity’s SOPs
• Understand the disease process or condition under study

Education/Experience

• Bachelor’s degree and 2 years relevant experience in the life science industry OR
• High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND1 year Clinical Research Coordinator experience
• Associate’s degree with 4 years relevant experience in the life science industry OR

Required Licenses/Certifications

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

Required Skills

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

Required Physical Abilites

• Communicate in person and by a telephone
• Limited walking required Limited to lifting up to 30 pounds
• Sit or stand for long periods of time Travel locally and nationally

Velocity is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. We are an E-Verify Employer in the United States.