Clinical Research Coordinator Ii

Vor 4 Tagen

Wiesbaden, 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 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**:
**Role & Responsibilities**:

- Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelinesand Velocity’s SOPs
- Develop, coordinate, and implement research and administrative strategies to successfullymanage assigned protocols.
- Maintain confidentiality of patient protected health information, sponsor confidentialinformation and Velocity confidential information
- Verify and escalate patient safety concerns by ensuring all adverse events, serious adverseevents, and adverse events of special interest are followed and reported in accordance withthe protocol and Velocity SOPs.
- Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timelymanner
- Ensure staff are delegated and trained appropriately and documented
- Create, collect and submit regulatory documents to Sponsors and IRBs as required perprotocol, GCP/ICH regulations and IRB requirements.
- Create and execute recruitment strategies defined by Clinical Research Team
- Understand key timelines, endpoints, required vendors, and patient population for eachassigned protocol.
- Understand product development lifecycle and significance of protocol design includingcritical 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 mínimal 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.
- Proficienct in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
- Demonstrated leadership ability

**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

Velocity is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. We are an E-Verify Employer in the United States.

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