Clinical Research Coordinator II

Velocity Clinical Research, Inc.; High Wycombe; On-site; GBP 28,000 - 42,000; Full time

Job summary

Velocity Clinical Research, Inc. is seeking a Clinic Research Coordinator II to oversee multiple trials from start-up through close-out in accordance with the protocol, GCP, and company SOPs. This on-site role in Plymouth requires meticulous data handling and participant safety oversight.

The coordinate will manage start-up activities, site QC, subject recruitment, regulatory submissions, and vendor relationships while collaborating with sponsors, CROs, and our clinical research team.

Qualifications

• Bachelor’s degree and 2 years relevant life sciences experience.
• Associate’s degree with 4 years relevant experience.
• High school graduate with 6 years relevant experience in life sciences and 1 year Clinical Research Coordinator experience

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 development review, scheduling subjects, protocol training,collection of regulatory documents, conducting visits, ensuring data is entered in a timely mannerand 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.
• 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 escape patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with theprotocol 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 prescreens.
• Create and execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Understand the disease process or condition under study
• Collaborate with Clinical Research Team to develop Quality Control strategy for reviewingone’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

Skills

Medical terminology

Professional communication

Team player

English proficiency

Organizational skills

Problem solving

Education

Bachelor’s degree in life sciences or related field

Associate’s degree with 4+ years life sciences experience

High school diploma with 6+ years life sciences experience

Tools

MS Office

Computers

Data entry systems

Fax and copier

Job description

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.

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.

Responsibilities

Duties/Responsibilities:

• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines andVelocity’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 mannerand 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.
• 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 escape patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with theprotocol 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 prescreens.
• Create and execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• Understand product development life cycle and significance of protocol design including critical data points
• Understand the disease process or condition under study
• Collaborate with Clinical Research Team to develop Quality Control strategy for reviewingone’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

Education/Experience:

• Bachelor’s degree and 2 years relevant experience in the life science industry OR
• Associate’s degree with 4 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

Required Skills:

• Demonstrated 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
• 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

Required Physical Abilities:

• Sit or stand for long periods of timeTravel locally and nationally
• Communicate in person and by a telephone
• Limited walking requiredLimited 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.