Clinical Research Coordinator
2 weeks ago
Qualifications
- Training (appropriate to anticipated duties — such as nursing degree or diploma, physician's assistant, study-specific training, other as applicable to assigned responsibilities).
- Experience and training in the conduct of clinical research (specific experience and/or training in clinical research, including REB submissions, reporting and source documentation, handling dangerous biomedical goods, blood collection, trial management).
- A thorough understanding of applicable regulatory requirements, principles of ICH GCP (E.6) and biomedical research ethics.
Responsibility
Under the direction of the Principal Investigator or sub-investigator, manage the conduct of clinical research activities.
Duties
- Develop management systems and prepare for study initiation:
Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
Review with the Principal Investigator the inclusion/exclusion criteria, overall structure and requirements of each protocol
Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity
Review the worksheets for accuracy and clarity
Utilize “all” resources made available for patient recruitment (i.e.. Other physician EMRs when access has been granted at regular intervals)
Ensure that the randomization procedure is followed as per protocol guidelines
Patient binders must be prepped prior to visit (this includes all bloodwork, ECG interpretation reports, CXR, Spirometry results, physician communications, adverse event reports, etc. must all be printed and filed in the binders AND presented to PI prior to entering patient clinic room
Document protocol exemptions and deviations.
Ensure adherence to protocol requirements
Review laboratory data, inform investigator of abnormal values and document daily
Report to primary care provider as appropriate
Manage administration of investigational therapy
Maintain dispensing logs, maintain temperature logs for room, fridge, etc.
Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
Oversee/Perform specimen collection, storage and shipment
Attend study-related meetings as appropriate
Communicate regularly with the Principal Investigator, monitor (and others responsible for conduct of the research) about study-related issues
Enter EDC on time
Check for expired lab kits at regular intervals
Participate in weekly team meetings
Organize binders, signatures, and pending items prior to monitoring visits
Record data and study documentation:
Record data as directed using the appropriate media or platform
Follow procedures for access and security for electronic data entry
Review keyed data for accuracy, as needed
Send data to the data collection center on a timely basis
Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
Correct and edit data as directed and as appropriate.
Monitor and report adverse events:
Assess, document and record all AEs as outlined in the protocol
Report serious AEs to the Principal Investigator, Sponsor and IRB (and others as required by funding source or as outlined in the protocol).
Regulatory documentation:
Know and understand all regulatory requirements associated with the conduct of the study assigned
Maintain files and documents as regulations dictate
Ensure that all required documentation is complete and appropriately filed.
Management of site activities during audits and inspections:
Prepare for quality assurance audits and regulatory inspections, as needed
Provide all required documentation to auditors
Make all appropriate corrections as requested by auditors
Management of ancillary staff:
Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).
**Salary**: $25.00-$28.00 per hour
**Benefits**:
- On-site parking
- Paid time off
Schedule:
- Monday to Friday
COVID-19 considerations:
All patients are required to wear a face mask.
Ability to commute/relocate:
- Niagara Falls, ON: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (preferred)
**Experience**:
- clinical research: 1 year (required)
**Language**:
- English (required)
Work Location: One location
Application deadline: 2023-01-20
Expected start date: 2023-01-23
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