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Clinical Research Coordinator/administrative

4 months ago

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

Gordon Sussman Clinical Research Incorporated is a healthcare organization dedicated to advancing medical research and improving patient outcomes. Our team is committed to conducting clinical trials and delivering high-quality care to our community. We are seeking a motivated and organized individual to join us as a Clinical Research Coordinator/Administrative Assistant.

As a Clinical Research Coordinator/Administrative Assistant, you will play a vital role in supporting our clinical research efforts and ensuring smooth administrative operations. Your responsibilities will include, but are not limited to:

- Assisting in the coordination and management of clinical research studies from initiation to closeout.
- Recruiting and screening study participants, obtaining informed consent, and maintaining accurate participant records.
- Coordinating study visits and procedures, ensuring compliance with study protocols and regulatory requirements.
- 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, TempTests and questionnaires
- Collecting and managing study data, maintaining study databases, and preparing reports for principal investigators and regulatory agencies.
- Perform blood and urine collection as well as processing and shipping in accordance with IATA guidelines
- 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
- Submit REB from start-up to close-out of clinical trials
- Providing administrative support to the clinical research team, including scheduling meetings, managing correspondence, and maintaining filing systems.
- Assisting with compensation related to clinical research activities.
- Liaising with study sponsors, contract research organizations (CROs), and regulatory agencies as needed.
- Ensuring compliance with Good Clinical Practice (GCP) guidelines, institutional policies, and regulatory standards.
- Submit REB from start-up to close-out of clinical trials.
- Provide administrative support for the autoinflammatory and atopic dermatitis programs
- Perform literature reviews
- Provide administrative support to the medical clinic as necessary

**Qualifications**:

- Previous clinical research/coordination experience is an asset
- 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.

Please note that this job description is intended to provide a general overview of the position. Other duties may be assigned as necessary to meet the needs of the clinic and research team.

Please submit your resume highlighting relevant experience for consideration.

**Salary**: $20.00 per hour

Flexible Language Requirement:

- French not required

Schedule:

- 8 hour shift
- Monday to Friday
- Overtime

Supplemental pay types:

- Overtime pay

Ability to Commute:

- North York, ON M3B 3S6 (required)

Work Location: In person

Application deadline: 2024-02-23