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Clinical Research Associate

22 Jul 2008

The Pharma division of Hays specializes in the placement of mid to upper lever staff involved in drug discovery, clinical development, post-approval services and commercial activities.

Our client portfolio spans the world's leading life sciences companies in the pharmaceutical, biotechnology, generics, CRO, consulting and medical device industries. These organizations have come to depend on our professional service, innovative solutions and global reach.

With 21 offices around the world and over 350 people working through Hays Pharma and a global database of pharmaceutical professionals, we will successfully search and place over 1,500 pharma & biotech professionals this year.

Our knowledge of the specialist industries and rigorous screening allows us to identify ideal candidates and serve both clients and candidates with our sound expertise in the most professional manner.

Clinical Research Associate - CRA

General Duties/Responsibilities

Conducts investigational site selection, initiation, periodic and termination visits. Serves as liaison between the sponsor and the investigator, serves as a resource for investigational site queries, and participates in project team meetings and sponsor telephone conference calls on a regular basis.

Travels to investigational sites to verify that the rights and well-being of human subjects are protected; the reported trial data are complete, accurate, and verifiable per source documents; and that the trial is conducted in compliance with the currently approved protocol, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs) and applicable regulations.

Other responsibilities include verifying proper storage conditions, accountability, and disposition of the investigational products; maintenance of up-to-date and accurate investigator study files; and accurate recording and reporting of adverse events. Writes and submits written reports of investigational site findings. May be involved in organizing or participating in Investigator's Meetings, study report writing, and the development of Protocols, Case Report Forms and Study Procedures Manuals.

Maintains a high level of professional expertise through familiarity with regulatory and clinical literature and continuous education.

Required Experience

Minimum of 2 years experience as a Clinical Research Associate (CRA) with primary site monitoring responsibilities
Knowledge of FDA, HPFB and/or international regulatory requirements and ICH required
Ability to travel 60% required

Education Requirements

Bachelor's degree required; R.N. or B.S.N. strongly preferred
ACRP certification preferred

Job Location Montreal, Quebec
Type of Work Full time

Interested, qualified applicants should submit a cover letter and resume in confidence to jaime.bridge@hayspharma.com

Or call 905-366-0342 to inquire.

Our client is dedicated to providing work life balance. They offer a competitive salary with bonus and perks.

For further information please contact

Jaime Bridge
Email: jaime.bridge@hayspharma.com

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