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Clinical Trial Coordinator
2 weeks ago
Position: Clinical Trial Coordinator
Site: Spectral Medical Inc.
Department: Clinical Operations
Reports to: Clinical Trial Manager, Clinical Operations
Hours: 37.5 per week
Status: Permanent Full-Time
Spectral Medical Inc. (SMI) is looking for an experienced professional to fill the key role of Clinical Trial Coordinator for our TIGRIS clinical trial.
**Qualifications**:
- Bachelors of Science (BSc.) or equivalent
- Clinical trial management or equivalent
- Knowledge of the clinical trial process. Knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements
- Understanding of the regulatory progression of establishing and maintaining clinical sites
- Ability to clearly and effectively communicate within the team, CRO, clinical sites and vendors
- Excellent organizational skills, detail oriented and the ability to manage multiple projects
- Excellent oral and written skills; ability to work independently and adjust to a rapidly changing environment
- Advanced Microsoft Office Word, Excel and Power point programs knowledge and understanding
- 2+ years’ experience in pharma and/or, biotech clinical research
- 2+ years’ experience and knowledge in document management
- Demonstrated success at completing projects accurately and on time
**Responsibilities**:
- Manage and maintain a controlled records management system for electronic trial master file and related clinical trial documents and conduct routine quality and completeness reviews of study documents and trackers to ensure proper filing, maintenance, and archiving of all documents
- Prepare and maintain administrative logs and trackers including but not limited to Regulatory Documents Collection tracker, eTMF tracker, FDA Submission tracker, Central IRB Submission tracker, Site Shipments tracker etc.
- Liaison with clinical trial sites, CRO and internal study team to facilitate the collection, filing and tracking of regulatory documents and other related study documents, including monitoring reports
- Collect and compile the set of study documents required for the release of investigation product to trial sites, for review by the Project Manager and Quality Assurance
- Prepare Study and Site level Regulatory Ethics submissions and attain Regulatory Ethics approval including but not limited to Initial Ethics submissions, SAE Reports submission, Protocol Deviations submission, Study Advertisements submission etc./
- Review and prepare site specific ICFs for ethics submissions
- Respond to all regulatory submission follow up inquiries in a timely manner and assist with other study related regulatory submission preparations as required
- Prepare all Study and Site level study renewal submissions in order to receive the study renewal approval in a timely manner
- Monitor and manage the clinical study mailbox on a daily basis
- Prepare regulatory packages and study start-up binders and tools for clinical trial sites and coordinate shipment of trial materials, trial equipment’s and supplies to clinical trial sites as necessary
- In co-operation with Quality Assurance, complete Investigational Product over labeling procedure as per study protocol requirement and coordinate shipment of investigational products to the investigative sites and 3PL, also manage and track monthly and quarterly clinical equipment and supplies inventory in co-operation with Finance
- Coordinate site trainings with study trainers, CRAs and clinical site study coordinators, as applicable (e.g. Protocol related training, EAA and PMX training, eCRF training, SIV etc.)
- Coordinate meeting activities such as organizing and planning of meetings (e.g. monthly management overview meetings, clinical team meetings), and scribes meeting minutes.
Spectral Medical Inc. thanks all applicants, however, only those selected for an interview will be contacted.
Flexible Language Requirement:
- French not required
Schedule:
- 8 hour shift
Ability to commute/relocate:
- Etobicoke, ON: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (required)
**Experience**:
- pharma and/or, biotech clinical research: 2 years (preferred)
Work Location: Hybrid remote in Etobicoke, ON
