Clinical Research Associate
i-Pharm ConsultingJob Description
Travel: Required for investigator site visits
Employment Type: Full-time / Permanent
We are seeking a skilled and motivated Clinical Research Associate I/II to work in an outsourced model, working via a CRO but embedded within a pharma environment. This role involves monitoring and managing clinical trial sites to ensure compliance with protocols, regulatory requirements, and sponsor expectations.
We are currently hiring for various locations in Canada.
Key Responsibilities
- Conduct monitoring visits including site initiation, routine monitoring, and close-out visits in alignment with Good Clinical Practice (GCP) standards.
- Collaborate with clinical sites to support patient recruitment and study execution.
- Administer protocol and study‑related training to site staff and maintain ongoing communication.
- Evaluate site compliance with study protocols and regulatory guidelines; identify and report quality issues.
- Track study progress including regulatory submissions, patient enrollment, data collection, and query resolution.
- Ensure proper documentation and maintenance of regulatory and study files.
- Work closely with study teams and provide timely reports and documentation.
- Support financial and contractual site activities as applicable.
Qualifications
- Bachelor’s degree in a life sciences or healthcare discipline.
- Minimum 2 years of clinical monitoring experience, preferably in clinical trials.
- Strong knowledge of GCP and ICH guidelines.
- Bilingual in English and French is highly preferred.
- Excellent organizational, communication, and problem‑solving skills.
- Proficient in Microsoft Office applications and electronic data capture systems.
- Ability to travel extensively as required.
- Valid driver’s license.
Additional Information
- This role requires residency in the country of employment.
- Candidates must demonstrate the ability to work independently and collaboratively with global study teams.
- Initial 6‑month contract
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