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WE ARE LOOKING FOR
LIFE SCIENCES GRADUATES FOR POSITIONS OF
REGIONAL CLINICAL RESEARCH
ASSOCIATES These exciting
careers involve creative challenges of moving from theoretical abstractions to humane, practical clinical interventions
that are needed to improve health care system's performance and save lives! A
Clinical Research Associate (CRA) is a professional who administers and monitors
the progress of a clinical trial (pharmaceuticals, biologics, or devices) on
behalf of a sponsor (Pharmaceutical Company). A
clinical trial is a scientific study of the effects, risks and benefits of a
medicinal product, whether it is new drug substances and/or currently marketed
drugs. A CRA might also be called a clinical research (or trials) monitor,
executive, scientist or coordinator, depending on the company. You
don't have to be a health-care professional in order to join this exciting
career, although you need to be at least BSc in life sciences or related field
and have a good knowledge of Good Clinical Practice (GCP) Guidelines. They
represent an international quality standard that is provided by International Conference on Harmonisation (ICH) - an international body that defines standards which governments transpose into regulations for clinical trials involving human subjects.
Good Clinical Practice guidelines include protection of human rights as a subject in clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds.
Good Clinical Practice Guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and
monitors ( Clinical Research Associates).
Project description:
Our
client is currently planning to launch clinical research activities and is looking
for regional / home-based Clinical Research Associates. This
project involves evaluation of the safety and efficacy of multiple doses
of investigative product in subjects undergoing coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass
(CPB). This study is seeking to establish a quantitative proof of superiority of
Cereprotec preventive treatment over placebo treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.
Role Description:
- Performs and coordinates all aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the
safety and efficacy of investigational products and/or medical devices.
- Conducts site visit to determine protocol and regulatory compliance, and prepares required documentation.
- Represents Cereprotec in the global medical research community and develop
collaborative relationships with investigative sites and client company personnel.
Education and Experience:
- At least Bachelor's Degree in life sciences or related field or certification in a related allied health profession from an
appropriately accredited institution
- research experience or strong seasoning as a health care professional with an appropriate combination of management
experience and/or directly related experience in a specific
therapeutic setting that may be substituted for monitoring experience.
- Effective clinical monitoring skills to include conduction of qualification, initiation, monitoring and close out visits; or
health care setting management skills; or core therapeutic
expertise
- Excellent understanding of or ability to attain and maintain a working knowledge of GCPs and applicable SOPs
- Basic computer skills and ability to learn and become proficient with appropriate software
- Effective oral and written communication skills with ability to communicate effectively with medical personnel
- Strong customer focus and excellent interpersonal skills
- CRA certificate is an asset
- Proven flexibility and adaptability
- Ability to work in a team environment and independently as needed
Work Conditions
Starting salaries range from $ 45,000 to $ 65,000 USD
Salaries with 3 and more years of experience range from $65,000 to $ 95,000 USD
Apply on line:
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