# Clinical Trial Coordinator- Regulatory

**Company**: Fortrea
**Location**: Durham
**Work arrangement**: remote
**Job type**: full-time
**Salary**: $65-75K
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Durham/Clinical-Trial-Coordinator---Regulatory---Remote-US_266803-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/clinical-trial-coordinator-regulatory-7dee1391-96b/

## Description

We are seeking a Clinical Trial Coordinator – Regulatory to serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines.

**Responsibilities:**

- Serve as contact for project team and investigative sites, conduct site contacts and document contacts for assigned sites as required per study guidelines, including creating contact reports for each telephone session with sites.

- Monitor site performance and implement action plans for sites not meeting expectations, in conjunction with the CRA.

- Assist CRAs with preparation for site visits, such as running reports, QC of files, and resolving action items from previous visits.

- Perform Case Report Form review, query generation and resolution against established data review guidelines, under direct supervision on Fortrea or client data management systems.

- Assist with the coordination of study visits and shipment of drug, ancillary supplies and laboratory kits/samples.

- Manage sites to ensure subjects are complying with protocol requirements, study visits, and timelines.

- Liaise with the project team and others to distribute and track clinical trial supplies.

- Proactively work with sites and project teams to ensure maintenance activities are completed for assigned sites as applicable in region.

- Demonstrate an understanding of the purpose of CTMS, how to use it, and how to navigate within the different sections.

- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities as applicable in region.

- Facilitate translation and back translation of all necessary documents as appropriate for local country requirements and as needed regionally.

- Attend meetings as needed, and present at meetings.

**Requirements:**

- At least one year of experience in a related field, such as medical, clinical, pharmaceutical, laboratory research, data analysis, or technical writing.

- 1-2 years of clinical research experience.

- Basic understanding of biology and biological processes.

- Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines, and GCP.

- Good organizational and time management skills.

- Good communication skills, oral and written.

- Exhibits general computer literacy.

- Works efficiently and effectively in a matrix environment.

**Qualifications (Minimum Required):**

- University/College degree in life science, or certification in a related allied health profession from an appropriate accredited institution.

- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

**Physical Requirements:**

- Ability to sit for extended periods and operate a vehicle safely.

- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

- Light to moderate lifting and carrying, with a maximum lift of 15-20 lbs.

- Regular and consistent attendance.

- Varied hours may be required.

**Target Pay Range:** $65-75K

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## Skills

### Required
- clinical trial coordination
- regulatory compliance
- site management
- data management
- communication

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Durham/Clinical-Trial-Coordinator---Regulatory---Remote-US_266803-1?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)