Clinical Research Project Assistant

6 months ago

Toronto, Canada SickKids Full time

**About SickKids**:
Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education. Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day. SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.

When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of _Healthier Children. A Better World_.

Don’t miss out on the opportunity to work alongside the world’s best in paediatric healthcare.

**Position Description**:
**The neurosurgery and neuro-oncology programs within the brain tumor research centre at the Hospital for Sick Children are excited to offer a unique opportunity for a clinical research assistant to work with both teams on innovative clinical trials.**

**BASIC FUNCTION: The individual will have reporting responsibilities to the specific trial lead and supported/mentored by the neuro-oncology and neurosurgery program heads as well as the project manager who will be responsible for the execution of the clinical trials.**

**About Focused Ultrasound**
- Focused Ultrasound (FUS) is a non-invasive, image guided surgical modality that can be used to lesion deep brain targets or open the blood brain barrier in various brain-based disorders

**JOB RESPONSIBILITIES**:
**Primary responsibilities will include, but not be limited to, the following**:

- Under the supervision of the clinical trials project manager, help open and execute clinical trials in neuro-oncology and neurosurgery
- Support all aspects of clinical trial coordination from study start-up to completion including performing informed consent procedures, enrollment, organizing study visits per protocol, executing all protocol related study activities
- Liaise with study personnel at coordinating sites to maintain flow of study activities
- Assists in study recruitment and coordination of study visits
- Monitors study activities to ensure compliance with protocols and with regulatory and institutional polices
- Maintains required records of study activity including case report forms, clinical records, and regulatory forms
- Schedules required study visits and assessments, coordinates with internal staff and investigators as well as communicates appointments to the patient and/or their legal guardian(s)
- Records adverse event data and confers with investigators regarding the reporting of events to oversight bodies
- Identifies protocol problems, informs investigators of problems, or assists in problem resolution efforts such as protocol revisions
- Involved in all aspects of data entry for oncology pediatric trials trial data management
- Support team members in preparation for site monitoring visits or potential audits by assisting with completion of electronic and paper case report forms
- Familiarity with all active protocols and assist with patient flow during treatment days and/study visits
- Assist with general administrative tasks related to the conduct of research study activities
- Provide support to study patients by helping them navigate the hospital during scheduled study visits and assessments
- Assist with amending of study documentation as well as collecting/maintaining all pertinent study regulatory documents as required

In addition, you will be expected to:

- Work within the larger context of Sick Kids Hospital and observe Hospital and Research Institute rules and regulations, policies, procedures, practices, safety procedures and current legislation, in particular the Human Rights Code regarding discrimination and harassment.
- Ensure the confidentiality of patient, employee and Hospital information at all times.
- Work cooperatively and constructively with the other members of staff.
- Perform the above functions in a manner which reflects Sick Kids Hospital philosophy and mission of service, while promoting and maintaining good public relations with patients, visitors and staff.

**ESSENTIAL QUALIFICATIONS**:

- Bachelor’s degree, Science/or Health Science preferred
- Experience with Good Clinical Practice, clinical research trials and electronic data capture databases preferred
- Strong interpersonal, time management, and organizational skills
- Strong attention to detail required
- Experience with pharmacy nomenclature and /or neuropsychometric assessments preferred
- Familiarity with Research Ethics Board submissions is an asset
- Experience in clinical trial coordination is an asset
- Training in Biosafety, WHMIS, and Occupational Health and Safet

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