Regional Clinical Coordinator Ii

vor 1 Woche

Salzburg, Österreich MedQIA, LLC. Vollzeit

**This is a independent contract role, working remotely within this region.**

**COMPENSATION**:$30-35 per hour US dollars

**ROLE**:Regional Clinical Coordinator II

**DEPARTMENT**:Clinical Operations

**DESCRIPTION**:
Responsible for site management and all applicable aspects, or designated areas, of a project.

**REPORTS TO**:Director of Clinical Operations

**RESPONSIBILITIES & ACCOUNTABILITIES**
- Manages all clinical sites within delegated region for the entire scope of the study.
- Identifies project expectations and ensures required activities and documentation occur and are appropriately maintained.
- Operates within the project parameters while ensuring compliance with applicable regulatory, internal and project-specific requirements.
- May serve as the primary liaison with sponsor and sponsor-designated representatives.
- Communicates with either the sponsor (or designee) or directly with clinical sites to coordinate personnel training and equipment credentialing, as well as assessment of data transfer capabilities.
- Oversees project activities, ensures protocol adherence and addresses non-compliance issues, as appropriate.
- May write or contribute to standard operating procedure documentation.
- Provides the necessary training or coordinates with personnel, to provide clinical site training.
- May be required to travel for Investigator meetings, trainings, or other meetings/events per request
- Performs and/or participates in internal and external project-related audits and audit
- related activities. Attends and/or presents at meetings with sponsors.
- Performs other departmental activities as needed and upon request.
- Able to work 40-60 +/- hours a month
**EDUCATION & EXPERIENCE**:

- Requires undergraduate degree or certificate, preferably in science, business or related field
- A minimum of 5 years of experience with Medical Device, Pharmaceutical and/or Clinical Research Industry, required.
- Working knowledge of regulations and standards related to clinical trial management for medical drugs and devices (such as GCP, FDA 21 CFR 320 and 812).
- Proficient in Microsoft Word, Excel, PowerPoint and experience using database software.
- Excellent written and oral communication skills.
- Excellent Organizational skills and attention to detail.
- Strong interpersonal skills and the ability to work with deadlines and manage multiple priorities.

**Job Types**: Part-time, Contract

Pay: 30.00€ - 35.00€ per hour

Application Question(s):

- Do you have working knowledge of regulations and standards related to clinical trial management for medical drugs and devices (such as GCP, FDA 21 CFR 320 and 812).

**Education**:

- Bachelor's (required)
**Experience**:

- Clinical trials management: 5 years (preferred)

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