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Clinical Research Coordinator I
Company | Velocity Clinical Research, Inc. |
Address | Omaha, NE, United States |
Employment type | FULL_TIME |
Salary | |
Category | Biotechnology Research |
Expires | 2023-06-04 |
Posted at | 1 year ago |
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.
- The Clinical Research Coodinator I conducts and manages clinical trials in accordance with the study protocol,GCP, and Velocity’s SOPs.
- Implement research and administrative strategies to successfully manage assigned protocols.
- 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.
- Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information
- Promote respect for cultural diversity and conventions with all individuals.
- Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
- Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
- Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
- Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
- 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.
- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs
- Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
- Execute recruitment strategies defined by Clinical Research Team
- Ensure staff are delegated and trained appropriately and documented
- Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.
- Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries
- High School Graduate and/or technical degre with minimum of 3 years relevant experience in the life science industry
- 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
- Phlebotomy if applicable and required by state law
- Intramuscular dose administration and preparation if applicable and required by state law
- Demonstrated verbal, written, and organizational skills
- Demonstrated ability to work independently, plan and prioritize with some guidance
- Demonstrated problem solving and strategic decision making ability.
- Demonstrated ability to work as a team player
- 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 interpersonal and communication skills
- Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
- Demonstrated bility to work in a fast-paced environment
- Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.
- Demonstrated ability to follow written guidelines
- Demonstrated ability to read, write, and speak English
- Demonstrated ability to multi-task
- Must be detail oriented
- Limited walking required
- Communicate in person and by a telephone
- Limited to lifting up to 30 pounds
- Travel locally and nationally
- Sit or stand for long periods of time
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