Clinical Research Coordinator I

Velocity Clinical Research, Inc.; Hampton (VA); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

Company holidays

401(k) with company match

Annual incentive program

Job summary

Velocity Clinical Research, Inc. is seeking a Clinical Research Coordinator I to conduct and manage clinical trials in line with study protocols, GCP, and Velocity SOPs.

The role includes coordinating start-up activities, subject recruitment, visits, data entry, and regulatory submissions, while ensuring safety and rigorous data quality. Qualifications include a Bachelor’s or equivalent with experience in life sciences, strong communication skills, and the ability to work in a fast-paced team.

Qualifications

• Bachelor’s degree with 1 year of relevant experience in life sciences or related field.
• Associate’s degree with 2 years of relevant experience in life sciences or related field.
• High School Diploma/technical degree with minimum 3 years relevant experience in life sciences.

Responsibilities

• Conduct and manage clinical trials in accordance with protocol, GCP, ICH, and SOPs.
• Coordinate trial activities including start-up, subject recruitment, visits, data entry, and regulatory documents.
• Ensure patient safety and proper reporting of adverse events.
• Communicate with sponsors, CROs, vendors, and study staff to ensure timely execution.
• Maintain confidentiality of patient information and sponsor data.

Skills

Medical terminology

English proficiency

Communication skills

Teamwork

Multi-tasking

Organizational skills

Attention to detail

Problem solving

Professionalism

Education

Bachelor’s degree

Associate’s degree

High School diploma/technical degree

Tools

Microsoft Office

Computers

Fax machine

Copier

Multi-line telephone

Job description

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 Coodinator I conducts and manages clinical trials 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 and Velocity’s SOPs
• Coordinate, with supervision, 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.
• 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
• 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
• 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.
• Execute recruitment strategies defined by Clinical Research Team
• Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
• 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.

Education/Experience

Qualifications

• Bachelor’s degree with 1 year of relevant experience in the life science industry OR
• Associate’s degree with 2 years of relevant experience in the life science industry OR
• High School Graduate and/or technical degre with minimum of 3 years relevant experience in the life science industry

Required Licenses/Certifications

• Phlebotomy if applicable and required by state law
• Intramuscular dose administration and preparation if applicable and required by state law

Required Skills

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

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.