Clinical Research Associate
6 months ago
**About the Company**
KGK Science is a growing clinical research and regulatory services business that has served clients in North America for over two decades focusing on a wide variety of physiological and/or cognitive indications across the Natural Health Products, pharmaceutical, cannabis, and psychedelics spaces.
**Overview**
KGK Science is a world-leading Contract Research Organization that specializes in conducting human clinical trials and regulatory services for the Natural Health Product industry. KGK is a dynamic, fast-paced and friendly work environment that will suit an energetic and strategic thinker with clear vision and solid communication skills. This is an opportunity for a highly motivated professional individual seeking to join a respected company in an exciting and growing industry.
Working under direction of the Clinical Research Associate Manager, the Clinical Research Associate (CRA) will collaborate with the Clinical Research Coordinators, Researchers, Sub-investigators, data management, and multi-disciplinary health care teams to ensure the accuracy of data and preparation of participant profiles. Through exceptional attention to detail, you will assure that all clinical trial documentation is prepared and maintained using Good Clinical Practice.
**Qualifications**
**Required Education**:
- Bachelor or Master’s degree in Life Sciences
**Required Experience**:
- Minimum 2 years of experience as a Clinical Research Associate
- Experience in the Natural Health Product industry is an asset
**Other Qualifications**:
SOCRA certification or ACRP certification
**What can you expect to do?**
- Responsibilities include study planning, study start-up, study execution and study close-out.
- Verify the conduct of the clinical trial in compliance with currently approved protocol/amendment(s), with GCP and with the applicable regulation
- Verify that the rights and well-being of participants are protected and conduct monitoring to confirm participant safety and data integrity
- Maintains complete, accurate and essential documents in systems utilized for trial management
- Review clinical trial protocols and essential documents
- Create source documents for clinical trials and review electronic source to ensure accuracy
- Develop clinical trial training materials
- Conduct site initiation visits
- Primary liaison with external clinical trial sites
- Monitor clinical trial data
- Train applicable personnel on study guidelines
- Address logistics with research team, correct any deviations that may be present
- Address queries related to study protocol
- Work with the Data Management Team
- Review all protocol deviations and adverse events
- Conduct full monitoring and high-level monitoring of charts
- Ad hoc duties as required
**Preferred Skills**
Skills that would be an asset in this role include:
- Ability to work individually and as part of a team
- Knowledge of Office 365
- Strong verbal and written English communication skills
- Ability to drive process and manage multiple projects
- Strong problem-solving skills
- Attention to detail
- Accountable and accurate
- Adept in multi-tasking and working in a fast-paced environment
- Extensive knowledge of Good Clinical Practices
**How we hire**:
We thank all applicants for their interest, however, only those selected for an interview will be contacted.
We provide accommodation for job applicants with disabilities during the recruitment process in accordance with applicable laws.
**Benefits**:
- Dental care
- Extended health care
- Vision care
Schedule:
- Monday to Friday
Ability to commute/relocate:
- London, ON: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (preferred)
Work Location: In person
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