Required! - Clinical Research Associa...
Home  »  Community News  »  Required! - Clinical...
May
28
ragupathyrenganathan
Required! – Clinical Research Associate. – Courtesy (Pharma job.ca)
Pharma Job Portal
0
, ,

ProMetic Life Sciences Inc.

Clinical Research Associate 

ProMetic Life Sciences Inc. is a biopharmaceutical company specializing in the research, development, manufacture and marketing of a variety of applications. Based in Laval (Canada), ProMetic has R&D facilities in Canada, the U.S. and the UK manufacturing, facilities in the UK. ProMetic leads business development activities in the United States, Europe, Asia and the Middle East.

The department of Clinical Research & Regulatory Affairs of ProMetic BioSciences Inc. is looking for a Clinical Research Associate, to work at its head office in Laval, Quebec. Under supervision of the Chief Medical Officer, the Clinical Research Associate monitor and retrieve data at investigational sites of ongoing multi-centre clinical studies complexity to ensure consistency of study standards.

The mandate of the Clinical Research Associate will be mainly to:

  • Assist in monitoring tools and CRF development;
  • Conduct clinical trial study monitoring activities: Ensure regulatory and protocol compliance of investigator/investigative site, coordinate Sponsor’s communications with sites to ensure investigators’ responsibilities, manage investigative site(s), oversee investigators and site coordinators to ensure consistency across sites, and to minimize problems such as protocol deviations; initiate routine payments to clinical sites, assist with drug shipment to clinical sites as defined per project, conduct training at the sites on all study procedures, conduct prequalification visits, site initiation visits, interim monitoring visits, and closeout visits as required;
  • Assist in the development clinical research SOPs. Review, understand and comply with clinical research SOP’s.
  • Prepare correspondence and study documentation with appropriate archival of electronic and paper copies;
  • Review data files listings against CRFs;
  • Assisting with preparation of documents for regulatory submission;
  • Assist to the draft of newsletters;
  • Assist in the negotiation grants/budgets with investigators and vendors, and prepare contracts;
  • Act as ProMetic direct contact with assigned clinical sites;
  • Qualify investigators;
  • Assist in the organization of investigators meetings;
  • Prepare and deliver presentations to investigators ;
  • Perform other duties as required to accomplish the goals of the clinical department.

The selected candidates will hold a Bachelor degree in Life Sciences or in Nursing (B.S./B.A./RN) with at least two (2) years’ experience as a Clinical Research Associate in the pharmaceutical, biotechnology, biologics, medical device industries and/or at a contract research organization. The candidate must have an extensive knowledge of Good Clinical Practices (GCPs), preferably through certification. Bilingualism is essential (Both French and English). The selected candidate must be willingness to travel up to 70% of his time.

The following criteria are also required:

  • Strong written and verbal communication skills;
  • Proven interpersonal and organizational skills;
  • Proven ability to manage multiple projects;
  • Strong problem solving skills;
  • Ability to be assertive while utilizing good people skills to motivate sites personnel;
  • Ability to effectively prioritize all aspects of clinical trials being managed;
  • Ability to work efficiently under aggressive timelines;
  • Willingness to learn and accept new job tasks as defined by each project;
  • Good computer skills in Microsoft Office programs with emphasis on Word and Excel.

ProMetic offers a competitive compensation, a flexible work schedule and a casual working environment.

To apply, please send a cover letter and copy of your resume to hr with the following reference: CRA-PLI. ProMetic is an equal opportunity employer. Only chosen candidates will be contacted for an interview.  For more information about ProMetic, visit our website www.prometic.com.



Leave a reply

You must be logged in to post a comment.