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Job Details

Freelance Senior CRA / CRA II - South Korea

Company: Premier Research
Location: South Korea - home based
Reference: 877MN
Closing Date: 08 Mar 18
Type: Contract
Salary (£): Competitive
Benefits: N/A

Job Summary:

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality.  We are currently seeking freelancer Senior CRAs who possess experience ideally with Pediatrics and Rare Disease.

Requirements:

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for a talented and energetic freelance Senior Clinical Research Associate to join a team which ranks among the top five contract research organizations for consistently delivering services that meet customer expectations.

The Senior CRA will perform clinical trial monitoring activities in compliance with trial protocol, ICH-GCP/ISO 14155, applicable local laws and regulations, company policies, and quality standards.

He or she will manage study-site activities to ensure collection of accurate clinical data within prescribed timelines; identify, resolve, mitigate, and escalate risks and issues; take responsibility for multiple studies; and work independently with team support. 

You’ll be accountable for:

Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.

Scheduling site visits for monitoring as required by protocol monitoring visit windows.

Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.

You’ll be responsible for:

Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.

Planning day-to-day activities for study monitoring and setting priorities by site.

Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.

Working with the line manager and CM to ensure that visit metrics are maintained as required.

Gauging the quality of clinical deliverables and addressing quality issues with team members.

Providing accurate and timely trip reports and records of hours worked.

Managing query resolution with study sites and Premier Research data management operations.

Maintaining the project tracking system of subjects and site information.

Participating in Investigators’ Meetings as assigned by Project Managers.

Maintaining contact with investigator sites via telephone calls between visits.

Ensuring adherence to study timelines and budgets.

Identifying and escalating potential risks and identifying retraining opportunities for site study teams.

You’ll also contribute by:

Being a resource for other CRAs, mentoring junior-level staff and sharing knowledge and best practices.

Participating in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.

In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.

Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.

Apply for this job: Freelance Senior CRA / CRA II - South Korea

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
Wokingham,
RG41 2GY
England
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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