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).*
Our client is currently planning to launch clinical research activities and is looking for regional / home-based Clinical Research Associates.
- 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 the sponsor 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
Starting salaries range from $ 45,000 to $ 65,000 USD