Clinical Research Coordinator I

vor 7 Monaten

Leipzig, Deutschland Velocity Clinical Research, Inc. Vollzeit

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.

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
- Implement research and administrative strategies to successfully manage assigned protocols.
- 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.
- 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.

Qualifications:
**Education/Experience**:

- 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 Abilites**:

- 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

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