# CRA II/Sr CRA

**Company**: Syneos Health
**Location**: MDA-Remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/MDA-Remote/CRA-II-Sr-CRA---Moldova-Macedonia--Sponsor-dedicated-_25114499?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/cra-ii-sr-cra-c550b0dc-94e/

## Description

Syneos Health is seeking a CRA II/Sr CRA to join their team in Moldova/Macedonia. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits. They will also verify the process of obtaining informed consent, assess factors that might affect subject/patient's safety and clinical data integrity, and apply query resolution techniques.

Responsibilities:

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

- Verify the process of obtaining informed consent

- Assess factors that might affect subject/patient's safety and clinical data integrity

- Apply query resolution techniques

- Utilize available hardware and software to support the effective conduct of the clinical study data review and capture

- Verify site compliance with electronic data capture requirements

- Perform investigational product (IP) 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, communication logs, and other required project documents

- 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/communication to ensure project objectives, deliverables, and timelines are met

- Adapt to changing priorities to achieve goals/targets

- Act as primary liaison with study site personnel

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

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

- Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes

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

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## Skills

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

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/MDA-Remote/CRA-II-Sr-CRA---Moldova-Macedonia--Sponsor-dedicated-_25114499?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)