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Clinical Research Specialist II AHRC
Job Title:Clinical Research Specialist II AHRC
New Work Type:Full-Time Permanent
Salary Range:$32.34 - $40.43 per hour
FTE Assignment (Cas=0.000001):1
The Applied Health Research Centre (AHRC) of the Li Ka Shing Knowledge Institute is an Academic Research Organization (ARO) that provides clinical study project coordination and data management services to Investigators and sponsors both nationally and internationally. The AHRC supports and manages all aspects of the clinical study process including protocol development, study document development, clinical site management, clinical data management, data analysis and report writing. This position will offer the successful applicant a challenging and rewarding career within the Observational Epidemiology & Qualitative Research Unit (OEQRU) of the AHRC.
The primary role of the Clinical Research Specialist II will be to manage and coordinate assigned multi-site observational clinical research studies, working closely with the sponsor, vendors and the internal AHRC team. The CRS II will be responsible for meeting study milestones on time and within budget. Duties may involve writing study protocols and research reports, site selection, site management, training of internal and external staff, overseeing and/or performing study QA activities, overseeing the development of the eCRF and study database, overseeing data validation activities and responding to issues, preparing study documents, managing study meeting coordination, tracking study progress, tracking the study budget, internal and external study audits, communicating with the internal study team as well as the study sponsor, vendors, and sites, and ensuring that issues are resolved in a timely manner. The Clinical Research Specialist II will report to the Manager, Observational Epidemiology and Qualitative Research Unit and must be flexible to work beyond the job description at times as work demands.
DUTIES & RESPONSIBILITIES:
- Central coordination of multi-centre observational studies
- Coordinate study-related meetings, work collaboratively and communicate with internal team members, external stakeholders, vendors and consultants.
- General project management, including coordinating research activities in collaboration with investigators, proactive project risk identification and mitigation, setting project goals, track study recruitment and develop the study recruitment plan; and track study milestones.
- Develop and distribute study-related documents, such as the master Informed Consent Form, study aids, and other study documents
- Manage site payments and site contracts
- Support site selection and site start-up activities
- Coordinate study training materials and perform site training
- Manage the study supplies; track incoming/outgoing study materials
- Address complex protocol-related questions
- Ensure conduct of research is carried out in accordance with ICH/GCP guidelines, Tri-council policy statement and applicable regulations, as well as SOPs
- Contribute to proposal development, data set creation plans, report writing and presentation of research findings where necessary
- Prepare REB submissions relative to the initiation and conduct of observational studies
- Oversee data management activities, such as database set-up, database validation, data monitoring, and database auditing
- A BSc in a science or health-related discipline is required; a relevant graduate degree and postgraduate training in clinical trials management would be considered an asset
- Training in ICH/GCP and/or CCRP accreditation is desirable
- A minimum of 3 years’ experience in a similar role.
- Strong project management skills with the ability to manage multiple projects.
- Meticulous and capable of independent decision making with study data.
- Strong verbal and written communication skills and excellent interpersonal skills.
- Ability to work in a diverse team environment.
- Resourceful and results-oriented
- Familiarity with electronic data capture tools/research databases an asset.