Clinical Research Associate
3 weeks ago
**Job Description**:
Clinical Research Associate
**Education**:
I. 4 year Undergraduate Degree in Health Science
II. SOCRA Certification - preferred
**Experience**:
I. About 1 year
Competencies:
I. Demonstrated analytic, problem-solving and attention to detail skills
II. Documented expertise of provincial, national and international regulatory guidelines (e.g. PHIPA, PIPEDA, ICH-GCP, Tri-Council Policy Statement, etc.) is compulsory
Other:
III. Position has a level of accountability in that discussions/decisions regarding study documents are done with mínimal to no supervision
IV. Ability to multitask and change priorities without supervision
V. Position generates many competing priorities
VI. Position requires excellent organization, time management, people skills, ability to communicate and collaborate with internal and external stakeholders
VII. Position is highly detail oriented
Position Summary:
Responsible for the following aspects of the Clinical Trials process including coordinating activities, monitoring of study compliance and maintenance of a system to ensure effective data entry and data flow, ensuring patient safety, study start-up procedures, consenting patients, monitoring patients on trials and toxicity assessment under direction of the principal investigator, maintaining and updating databases, ethics submission and ongoing regulatory monitoring and trial procedures. Support monitoring visits, coordinating audits and all preparation and chart review, query resolution.
- Ensures quality assurance through accuracy and timeliness of submitted documentation and ensures that all data can be verified in the source document
- Maintains accurate data collection, through direct interviews with the protocol patients for the duration of the study and coordinates the order of investigations and appointments according to protocol requirements
- Reviews research protocols to determine applicability, impact and accessibility in collaboration with Clinical Trials Team.
Participates in a culture of safety which encourages prevention, reduces errors and safeguards patients from harm.
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