# SCRA I/II

**Company**: Syneos Health
**Location**: AUS-Remote
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/AUS-Remote/SCRA-I-II--Melbourne-Sydney-Brisbane-based-_25113961?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_aa19b692-a42

## Description

Syneos Health is seeking a SCRA I/II to join their Clinical Solutions team. The successful candidate will perform site qualification, site initiation, interim monitoring, site management, and close-out visits. They will also verify the process of obtaining informed consent, assess factors affecting subject/patient safety and clinical data integrity, and conduct source document reviews.

Responsibilities:

- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits

- Verify the process of obtaining informed consent

- Assess factors affecting subject/patient safety and clinical data integrity

- Conduct source document reviews

- Apply query resolution techniques remotely and on-site

- Utilize available hardware and software to support clinical study data review and capture

- Verify site compliance with electronic data capture requirements

- Perform investigational product inventory, reconciliation, and reviews storage and security

- Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness

- Document activities via confirmation letters, follow-up letters, trip reports, and communication logs

- Support subject/patient recruitment, retention, and awareness strategies

- Enter data into tracking systems as required

- Understand project scope, budgets, and timelines

- Manage site-level activities and communication

- Act as primary liaison with study site personnel

- Prepare for and attend Investigator Meetings and sponsor face-to-face meetings

- Provide guidance at the site and project level towards audit readiness standards

- May provide direct supervision, training, and mentorship to more junior level CRAs

Qualifications:

- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience

- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

- Good computer skills and ability to embrace new technologies

- Excellent communication, presentation, and interpersonal skills

- Ability to manage required travel of up to 75% on a regular basis

## Skills

### Required
- Good Clinical Practice
- ICH Guidelines
- regulatory requirements
- computer skills
- communication skills
- interpersonal skills

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/AUS-Remote/SCRA-I-II--Melbourne-Sydney-Brisbane-based-_25113961?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)