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Senior Clinical Research Associate

Category	Clinical Research
Job Ref	NK/HQ00012462
Job Type	Permanent
Salary	€ 30000.00 - € 50000.00 per annum
Location	Croatia

11 Mar 2010

Our client is a top global CRO. They are now looking for an experienced CRA to come on board as a Senior CRA in Croatia.

PURPOSE
Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic
areas. Ensure that clinical research studies are conducted in accordance with the protocol, standard operating procedures,
good clinical practice, and applicable regulatory requirements.

RESPONSIBILITIES
Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good
clinical practice.
Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to
manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to
applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment,
case report form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by
submitting regular visit reports and other required study documentation.
Act as a mentor for clinical staff including conducting co-monitoring and training visits.
May provide assistance to the CTL with design of study tools, documents and processes.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical
Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
In depth therapeutic and protocol knowledge as provided in company training
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
Strong written and verbal communication skills in the local language including good command of English language
Excellent organizational and problem-solving skills
Effective time management skills
Ability to manage competing priorities
Effective mentoring and training skills
Ability to establish and maintain effective working relationships with coworkers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
University degree in a health care (medical doctor, pharmacist, dentist) and previous on-site
monitoring experience gained before November 2007

For further information please contact
Alina Lapadatu
Email: alina.lapadatu@hayspharma.com

Services advertised by Hays Pharma are those of an Agency and/or an Employment Business