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About the Role
The Clinical Research Coordinator I conducts and manages clinical trials in accordance with the study protocol, GCP, and Velocity’s SOPs. This role is integral to Velocity's mission of bringing innovative medical treatments to patients by generating high-quality data and providing exemplary patient care.
Responsibilities
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs.
- 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, and 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 pre-screens.
- Execute recruitment strategies defined by the 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.
Requirements
- 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 degree with a minimum of 3 years relevant experience in the life science industry.
- Phlebotomy if applicable and required by state law.
- Intramuscular dose administration and preparation if applicable and required by state law.
- Demonstrated knowledge of medical terminology.
- Demonstrated ability in the use of computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Demonstrated ability 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.
- Ability to sit or stand for long periods of time.
- Ability to travel locally and nationally.
- Ability to communicate in person and by telephone.
- Limited walking required.
- Limited to lifting up to 30 pounds.
Skills
- Medical terminology
- Computers
- Microsoft Office software
- Fax
- Copier
- Multi-line telephone
- Verbal communication
- Written communication
- Organizational skills
- Interpersonal skills
- Teamwork
- English language proficiency
- Multi-tasking
- Following written guidelines
- Independent work
- Planning
- Prioritization
- Flexibility
- Adaptability
- Detail-oriented
- Problem-solving
- Strategic decision-making
- Professionalism
Experience Level
- 1 year of relevant experience
- 2 years of relevant experience
- 3 years of relevant experience
Education Level
- Bachelor’s degree
- Associate’s degree
- High School Graduate
- Technical degree
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- Company holidays
- 401(k) retirement plan with company-match
- Annual incentive program
About the Company
- 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.