Project Coordinator

1 week ago

الرياض, Saudi Arabia IQVIA Full time

**PURPOSE**

The project coordinator comprises an integral part of the research team at the site level. Working under the Principal Investigator, he/she is responsible for supporting the Principal Investigator in conducting the study in accordance with ICH-GCP, regulatory standards, Protocol study design and company standards. Depending on departmental organization, the CRC may also have responsibility for helping the Principal Investigator to look for potential patients in the medical records, maintain updated the Case Report Form, the Tracking Logs, the Investigator Study File and all the Ethics and Regulatory paperwork.

**RESPONSIBILITIES**
- Preparing for study initiation;
- Obtaining physician signatures;
- Support identifying potential Patients for the Study;
- Ensure Completing case report forms (“CRF”) as per timelines;
- Ensure Protocol Deviation documentation is as per GCP and Protocol requirement’s
- Maintaining tracking logs and study files;
- Submitting ethical and regulatory documents to IRB;
- Submitting the clinical study agreement for review;
- Attending investigator meeting(s);
- Maintaining study-specific supplies;
- Preparing for study closure and archiving.

**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**
- Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of applicable protocol requirements as provided in company training
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
- Good written and verbal communication skills including good command of English language
- Effective time management and organizational skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients at different sites.

**Role requirements**:

- Pharmacy background with 1-4 years of experience in hospitals
- Bachelor's degree in a healthcare or other scientific discipline and 1 year administrative support experience; OR equivalent combination of education, training and experience.
- Fluency in Arabic and English
- Extensive use of telephone and face-to-face interactions, which require accurate perception of speech
- Extensive use of keyboard requiring repetitive motion of fingers.
- Occasional travel.

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