Clinical Research Assistant

2 weeks ago

Toronto, Canada Sunnybrook Health Sciences Centre Full time

**Position title: Clinical Research Assistant**

**Status: Temporary Full Time**

**Classification: SRI appropriate - Grant Funded**

**Program: Neuroscience Program**

**Platform: Physical Sciences**

**Reporting to: Nir Lipsman**

**BASIC FUNCTION: The individual will have reporting responsibilities to Dr. Nir Lipsman, Director **for **Harquail Centre for Neuromodulation, and the Sr. Manager, Clinical Trials, Neurodegenerative platform. The key responsibilities will involve supporting patient recruitment, timely and accurate data entry as well as general coordination of Focused ultrasound (FUS) trials within the Harquail Centre for Neuromodulation at Sunnybrook Research Institute.**

**About Harquail Centre for Neuromodulation (HCN), at Sunnybrook Research Institute (SRI)**
- Focused Ultrasound 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 to potentially deliver therapeutics
- Researchers at SRI have the largest and most comprehensive experience with animal models of FUS and one of the world’s leading experience in clinical use of FUS
- SRI has published the world’s first experience with FUS in movement disorders and other disorders

**JOB RESPONSIBILITIES**

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

- Support all aspects of clinical trial coordination support in study start-up through completion including informed consent procedures, organizing study visits per protocol, executing protocol related study activities
- Liaise with Study Managers and SHSC/SRI personnel internally and externally to maintain efficient procedure flow
- Assist in study recruitment by reviewing patient charts/clinical notes against study inclusion/exclusion criteria
- Ensure compliance with protocols and with relevant regulatory and institutional polices
- Support maintenance of required study related records including paper and electronic case report forms, clinical records, and/or regulatory forms
- Assist in scheduling required study visits and assessments, coordinates with internal staff and investigators as well as communicate appointments to the patient and/or their legal guardian(s)
- Raise adverse event and/or side effect data to appropriate study staff and investigators regarding the reporting of events to oversight bodies
- Engage in all aspects of data entry, query resolution and follow-through Support team members in preparation for site monitoring visits or potential audits by assisting with completion of electronic and paper case report forms (clinical notes, treatment reports and trial charts)
- Familiarity with all neurodegenerative protocols and movement disorder procedure requirements, and assist with patient flow during treatment days and/study visits
- Provide support to study patients by helping them navigate the hospital during scheduled study visits and assessments.
- Support team’s knowledge translation and publication efforts with writing, literature reviews, and data processing as requested by Harquail Centre investigators
- Provide coverage where required for other platforms (oncology, psychiatry, movement disorders)

**Specific to Parkinson’s Disease Clinical Trials**:

- Schedule and assist in remote data collection for wearable sensors used in Parkinson’s Disease clinical trials pre and post intervention, including sensor deployment and related data management activities
- Keep records of equipment location and status; maintain equipment inventory and order additional equipment/supplies as needed for wearable sensor maintenance
- Head the remote sensor data collections of PD participants
- Assist with study materials, scheduling, and related sensor data collections for participants, organizing equipment transportation, manage incoming data, maintaining logs of data collection protocols, and supporting ordering and testing of additional equipment
- Develop wearable knowledge translation materials and support knowledge translation activities to both patients and clinical trial staff

**ESSENTIAL QUALIFICATIONS**
- Bachelor’s degree, Applied Health Sciences 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 Safety regulations.
- Working knowledge of general-purpose computer software (including, but not limited to Excel, MS Word, Power point)
- Ability to set priorities and manage time successfully to coordinate workflow around deadlines and shifting priorities

In addition, you will be expected to:

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