Clinical Research Coordinator

6 days ago

North York, Canada Gordon Sussman Clinical Research Inc. Full time

Dr. Gordon Sussman Clinical Research is looking for a full-time Clinical Research Coordinator to support various clinical trials in our North York clinic.

Responsibilities include but are not limited to:

- Support the clinical research department in ensuring the successful delivery of clinical trials
- Conduct clinical research studies according to the study protocol, GCP, and Gordon Sussman Clinical Research SOPs
- Obtain proper written informed consent from each study participant before participation in a study
- Screen potential study participants according to inclusion/exclusion criteria
- Execute all aspects of study visits - assessments, safety monitoring, and medication administration
- Perform delegated protocol-specific activities completely and accurately
- Obtain medical history, concomitant medications, vital signs, height, and weight as required per protocol
- Perform all necessary tests/procedures per protocol: blood work, ECGs, pulmonary function tests, skin prick tests, oral food challenges, injections, and questionnaires
- Perform blood and urine collection as well as processing and shipping
- Monitor and report all adverse events/SAEs to the principal investigator/sub-investigator(s)
- Create and complete source documents and any other research documents required for the successful conduction of clinical research studies
- Coordinate and implement all aspects of data collection and source documentation per ICH/GCP guidelines
- Enter data and resolve queries per sponsor requirements via multiple EDC platforms
- Liaise with sponsor monitors to review and discuss the conduction of clinical trials
- Submit REB from start-up to close-out of clinical trials

Qualifications:

- 2-3 years of previous clinical research/coordination experience
- Recognized certificate in clinical research (ACRP or SOCRA)
- Training in ICH/GCP guidelines
- Phlebotomy certification and experience
- Knowledge of IATA shipping regulations and basic laboratory procedures
- Ability to work independently or in a team-based environment
- Strong knowledge of medical terminology
- Knowledge of biostatistical methods and systematic literature reviews
- Experience working effectively with a wide variety of people at different levels including physicians, industry sponsors, and monitors
- Excellent interpersonal, verbal, and written communication skills
- Detail-oriented with exceptional organizational skills
- Excellent ability to set priorities and work independently with accuracy in a dynamic environment
- Proficiency in MS Office software - Word, Excel, etc.

**Salary**: From $44,500.49 per year

Flexible Language Requirement:

- French not required

Schedule:

- 8 hour shift
- Monday to Friday
- No weekends

Supplemental pay types:

- Overtime pay

Application question(s):

- Normal working hours are 8 AM - 4 PM. However, are you able to occasionally start work at 7 AM for team meetings, site-initiation visits, monitor visits, etc?

**Experience**:

- previous clinical research/coordination: 2 years (preferred)

Licence/Certification:

- recognized certificate in clinical research (ACRP or SOCRA) (preferred)
- phlebotomy certification and experience within the last year (preferred)

Work Location: In person

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