About the role

Project Coordinator II coordinating clinical trial site activation, documentation, and regulatory support at Indero, a dermatology and rheumatology CRO. Managing site communications, tracking systems, training, audits, and study logistics.

Responsibilities

Lead assigned site activation activities within established timelines and quality standards.
Coordinate, collect, review, and approve essential regulatory and clinical trial documents from investigator sites.
Act as the primary contact for assigned sites on operational and administrative matters.
Coordinate with Clinical Operations, Regulatory, and Data Management teams.
Identify and escalate potential site activation risks or delays to the Project Manager.
Maintain accurate information in the CTMS, eTMF, and other tracking tools.
Prepare meeting minutes, study trackers, reports, study correspondence, and site communications.
Support ethics committee submissions and country-specific regulatory requirements.
Coordinate project-specific training assignments and documentation.
Manage logistics for investigator meetings, study supplies, and ISF distribution.
Participate in audits and inspections and support responses to findings.
Contribute to process improvements, best-practice documentation, and SOP compliance initiatives.
Provide guidance to junior coordinators.

Bachelor’s degree in a field relevant to clinical research or equivalent experience.
1 to 2 years of experience in clinical research, preferably in a CRO, biotech, or pharmaceutical setting.
Sound understanding of GCP, ICH guidelines, and clinical documentation standards.
Strong interpersonal and organizational skills, with the ability to prioritize and manage multiple tasks.
Excellent written and verbal communication skills in English; bilingualism an asset.
Demonstrated ability to work independently and collaboratively within cross-functional teams.
Good knowledge of applicable Health Canada and FDA regulations/guidelines.

Flexible work schedule
Permanent full-time position
Company benefits package
Ongoing learning and development
Home-based position
Avantages sociaux complets (soins médicaux, soins dentaires, soins de la vue, REER, vacances, jours personnels, clinique médicale virtuelle, rabais sur le transport en commun, activités sociales)